LHR Consult

When quality matters

LHR Consult offers services related to quality management, operations and production, information security/data privacy, environmental protection, business ethics and legal advice within the health-care business, e.g. tissues & cells, assisted reproduction, pharma and biotech.

What Colleagues/Clients Say

Trusted by leading healthcare organizations across Europe

We have greatly benefited from Lars’ assistance in connection with an ownership transition of a specialist gynecological practice, including: Assistance with the application process for tissue center authorization related to the change of ownership. Review, updating, and preparation of new quality documentation. Setup of layout and a document management system. Establishment of registration and reporting of various incidents, adverse events, etc. General advisory support regarding clinic activities, potential shortcomings, and opportunities for improvement. Lars is a pleasant person who backs up his words with action and executes tasks quickly. He quickly understands the scope of the assignments, is curious about new processes, and is highly solution oriented. He comes with our warmest recommendations.

Our clinic has had the pleasure of working with Lars as we prepared for an upcoming change in clinic ownership. From the moment he was engaged, Lars approached the assignment with confidence and enthusiasm, quickly taking full ownership of the task. He worked highly independently and efficiently, quickly gaining an overview of existing conditions, processes, documentation and permits, communicating with relevant authorities, preparing for applications, setting up/re-constructing policies, operating procedures etc., filing/registration/reporting structures etc. to ensure full alignment with the overall quality management system.

During our weekly meetings, Lars presented clear and well-structured updates on his progress, enabling us to agree on next steps and future deliverables. On schedule, with minimal support, and an always positive attitude, he eventually delivered a complete application/documentation package for final review. Drawing on his extensive experience in the field, Lars also provided valuable input on existing and potential future clinic activities, including regulatory considerations, legal requirements, and practical options. We have been extremely satisfied with Lars’ contribution and can highly recommend him as a knowledgeable, reliable, and dedicated consultant.

Har haft et meget velfungerende og godt samarbejde med Lars, der har bidraget med GDPR input - herunder privatlivspolitik - i forbindelse med indsamling og opbevaring af persondata mv., ved lancering af sundhedsteknologisk applikation til brug for sundhedsfagligt personale i de 5 regioner.

We had Lars in the Clinic for 4 weeks working as an consultant.

Lars has helped us prepare for the upcoming relocation of our tissue center, including developing validation plans for equipment, facilities, and more. In addition, he has conducted gap analyses related to data protection, processes, and quality management. He has provided valuable input for our future operations in the new setting.

Lars is professional, reliable, and competent, with extensive expertise in tissue center and fertility legislation.

I had the pleasure of working with Lars at Vitanova Fertility, and I can confidently say he is one of the most dedicated and compassionate professionals I’ve worked alongside.

What stood out most was Lars’s professionalism, teamwork, and commitment to creating a supportive He brought positivity and calm to the workplace, even during the busiest days.

I highly recommend him to any organization looking for someone who brings not only expertise, but also empathy and integrity to their work.

I have worked with Lars for over 5 years now; I know firsthand that Lars performs with self-confidence in all work situations and I have numerous times experienced first hand that he is keen to go the extra mile to ensure high levels of competency and standard. His independent research, requiring initiative, and self-motivation are some of his main qualities. On top of this, Lars’ pleasant demeanor, professionalism and articulation are to be commended.

I would like to give a huge thanks to Lars who has very efficiently and skillfully reviewed, commented on, and suggested certain improvements to our clinic’s QM and GDPR systems, procedures and documentation. He also introduced new service providers in the andrology/IVF labs, prepared application for renewal of permits, investigated renewal of agreements with certified test labs and communicated with authorities regarding various outstanding issues.

Lars was well-regarded and very helpful to all teams. I could add to this a very good spirit and a pleasant person to collaborate with and I highly recommend him.

Tak for fantastisk og professionel sparring vedr. opstart af sædbank og udtagningssteder. Det forløb uden problemer. Jeg ser frem til vores fremtidige samarbejde.

Tak for et godt samarbejde og faglig sparring i Donor Network. Det har været en fornøjelse

Lars har en dybdegående indsigt, er konstruktiv, løsningsorienteret, indstillet på samarbejde og ikke mindst en behagelig person. Tak for det gode samarbejde omkring tilladelser og håndtering af donorer.

Lars, apart from being a true ray of sunshine for every room he walks in, has the remarkable and rare ability to be able to step back and see the big picture while never losing sight of crucial details; he connects the dots between the macro and the micro with ease, recognizing patterns and relationships that others would overlook. This unique brain, which I felt so similar to mine, allows him to anticipate challenges, identify improvement opportunities, and create solutions easily.
This is why he is the perfect fit for any company in need of a true nerd in the matters of Quality consultancy. I miss him already at Vitanova!

I know Lars from our cooperation on a major UK project with tough deadlines and a lot of pressure on deliverables. Lars was taking over as Privacy Lead within his team and didn’t waste any time in obtaining the right knowledge to properly and efficiently address the relevant privacy-related tasks. All the best for your new assignment , I am sure success will follow you...

I have had the privilege of working with Lars on a major project. Not only is he a wonderful colleague with a good sense of humor, he is also deeply professional when it comes to understanding processes, explaining his point of views, setting up solutions and delivering in time. Also, he is a trustworthy person who has gained the confidence of both the customer and project participants. I have been fortunate enough to work on the same project and exchanged information to help each other complete our deliverables.

I have come to know Lars as a very competent professional in the field of Quality Management. He has guided the company through the build up of the QM functions in compliance with increasing legal and public requirements. This involves the preparation of quality documents, training of employees, conducting an internal audit program, hosting third party audits and inspections by regulatory authorities, monitoring and implementation of national and international legal requirements, consulting and supporting company units, assessment and trend analysis of reported deviations, unintended Incidents and complaints, preparation of quality agreements with third parties, safety surveillance etc. I am very comfortable with him as our Quality Manager and look forward to many more years of efficient teamwork.

I am working with Lars on a project for a major UK insurance company, and I can say that Lars has always maintained a great overview of the project and key obstacles at hand. He has dealt quickly with concerns and has always worked to get the right resolutions in place. To my knowledge, he is a very diligent and responsible head of the privacy team.

Lars and I have worked together for just about 5 years now. He knows his way around people, does whatever it takes to help colleagues and gets things done – in time. He is extremely committed to quality, safety and compliance with guidelines and regulatory requirements. He strives for excellence and is a top performer who inspires all of us to give our best. Collaboration has always been very smooth and his work and assistance has made a huge impact on our success in the Sales Dept. He is a valuable team player and simply amazing at his job.

Lars and I have worked together at Storkereden Fertility Clinic since 2020, when he first established his private consultancy and presented the range of services he offers. Since then, he has acted as our Responsible Person, updated and maintained our quality management system, carried out audits on an ongoing basis, and supported the clinic during inspections. He has consistently kept us informed of developments in relevant legislation and has contributed significantly to the handling of ongoing regulatory and operational matters. In addition to his professionalism and expertise, Lars is a genuinely pleasant and approachable person to work with. He is positive, solution-oriented, and highly trusted throughout the organization. His support has been invaluable, and the clinic could not have managed without his help. We give Lars our strongest recommendation.

I have had the privilege of working with Lars for many years. Not only is he a wonderful colleague with a good sense of humor, he is also deeply professional. He has created quality management systems and implemented GDPR in a company based in both Denmark and several other countries and has established good cooperation with national and international authorities. He has a great network and is careful in everything he does. His work will be a cornerstone of any business.

I’ve had the pleasure of working with Lars, while he was the QM at European Sperm Bank. Lars is extremely knowledgeable in regard to quality management and proved a great support at audits. Lars implemented the GDPR within the company, in an industry handling private data from several parties, further spanning EU as well as 3 different national regulations. Furthermore, Lars created and updated SOPs for all areas of the business, through his work he knew the SOPs in minute detail and trained the employees in the SOPs relevant for the positions. On top of this, Lars managed the responsibilities as Responsible Person and communicated/collaborated closely with the regulatory authorities. Lars shows great passion for his work and combined with his great sense of humour makes him a fab colleague.

I’ve come to know Lars as a very responsible Privacy Lead. Lars is good at figuring out what’s going on and how to proceed.

Lars joined our team at a very crucial time and despite the challenges being faced by the team at the moment, he was quick to understand the challenges and ready with solutions to offer. He digs into whatever problems he encounters on this way to successfully manage the privacy team and deliverables agreed with the client. He is a good representative for our consultancy team and a very good leader to the team.

Lars was the company’s Safety Officer during our 6 years together in Medicon/Cyncron. I got to know him as a highly competent pharmacovigilance (PV) professional. He successfully used his diplomatic skills to navigate through the challenges of introducing PV in clinical drug development and building up a PV Dpt. from scratch. This was also the case when dealing with internal and external partners in the management of PV activities. He was always focused on compliance in all aspects of PV (incl. post marketing safety when acting as an external consultant) and prepared/ improved the company’s quality documentation along with the QA Dpt. All this could not have taken place, had he not been a team-player and a very likable person with a great sense of humor. I give Lars my best recommendations.

Lars is thorough, hard working, and persistent. He is direct and amicable, and I enjoyed working with him.

During his task to understand Vitanova IVF-laboratory procedures and evaluate our quality management system etc., he booked med in for a number of sessions. He was very interested in our work, and always had relevant questions and suggestions as how to make improvements. He is very open minded, easy going and nice to have around.

European Sperm Bank ville ikke være den samme uden Lars.

Lars er en kompetent, arbejdsom og flittig kollega. Han er altid imødekommende og ivrig efter at svare på mine spørgsmål eller have en faglig dialog om hvad det nu måtte være.

Når jeg henvender mig til Lars er han altid nærværende og lyttende.

Jeg holder specielt meget af Lars’ humor og evne til at være utrolig positiv i alle situationer.

Lars er en dejlig kollega at have!

Jeg har haft fornøjelsen af at arbejde sammen med Lars i European Sperm Bank i forbindelse med SOP træning, kvalitetssikring, persondatasikkerhed, implementering af nye processer, interne audits mv., hvor Lars’ evne til at arbejde systematisk og grundigt var af stor vigtighed. Jeg kan varmt anbefale Lars som en sød, dygtig og meget imødekommende kollega. En kollega jeg hver dag sætter stor pris på.

I have had the pleasure of working with Lars for a couple of years now. He works hard and diligently with whatever problem he is presented to, and is definitely a valuable asset for the company.

I have had the great pleasure to work with Lars since his start as a consultant in the company more than four years ago now. Over the years, he has successfully re-developed and expanded the company quality system, which has stood its test during several inspections and third party audits. Lars is a hardworking, resourceful, energetic and easy-going individual – and I have come to know him as a truly valuable asset to absolutely any team. He is a true team player, and always manages to foster positive discussions and bring the best out of other employees.

I can warmly recommend Lars.

Jeg har haft fornøjelsen af at arbejde sammen med Lars siden min start i Nordic Cryobank og har erfaret, at han er meget ærekær, flittig og dygtig til sit arbejde. Han er yderst hjælpsom og hurtig til at sætte sig ind i problemstillinger og på baggrund heraf levere solide løsninger. Han har en positiv indstilling til nye udfordringer han måtte blive stillet overfor og sætter en ære i at opretholde et meget højt niveau.

I got to know Lars from a huge project for a major global client, in which we were reviewing, partly implementing and managing the client privacy program. As the Privacy Lead and communication link between Cognizant and the client, he was very knowledgeable and highly business-minded. Also, his “straight talking” approach was a great asset for all stakeholders involved.

Lars and I have been working together on a project for a major insurance company for some time now. I’ve come to realize, that he knows his way around people – be it the client or his colleagues. He does whatever it takes to gets things done and deliver in time. Collaboration has always been very smooth - and his contribution to the team, has helped us out a lot. He is a valuable player in the consultancy team and a superb representative of the company.

Jeg har haft fornøjelsen at arbejde sammen med Lars de sidste par år 🙂 Lars arbejder systematisk, struktureret og målrettet. Han er yderst professionel og engageret i sit arbejde. Derudover er han en behagelig person, der med godt humør og positiv indstilling bidrager til at skabe en god og afslappet atmosfære på arbejdspladsen.

Lars is highly dedicated to his work. He is very systematic and thorough in his approach and you can always trust him to deliver what you agreed upon and in high quality. His attention to detail and constant overview have enabled us to make great improvements to our quality infrastructure.

I believe Lars can make a difference through his drive and commitment as well as his knowledge of QA related issues. He has a good sense of humor and will always try to see the positive side of things.It is a pleasure to have him as a colleague.

It has ben a pleasure to work with Lars for the last year in ALK.
Lars was hired to help prepare and collect all the information needed in the Pharmacovigilance System Master File (PSMF), based on the Good Pharmacovigilance Practice modules. He has a very optimistic way of approaching the workload and was determined to have the information needed from all relevant departments in time for finalising the PSMF. I can warmly recommend Lars to similar jobs.

I have known Lars for almost two years in my capacity as Client Service Manager at Nordic Cryobank Group. Lars is known for his good mood, positive spirit and willingness to follow through and execute. He is a dedicated and knowledgeable employee and an all-around great person. I have thoroughly enjoyed my time working with Lars, and it is my pleasure to recommend him for any future employee.

Lars was employed as Safety Officer in Cyncron A/S (formerly Medicon A/S) from Dec 2001. I was Lars’ line manager from Oct 2008 and prior to that, I interacted with Lars as an investigator for several years. During his time in Cyncron, Lars achieved a substantial knowledge of many therapeutic areas. This was enhanced by an intensive engagement in postgraduate education and duties as an external consultant at various pharmaceutical companies. On several occasions, sponsors expressed their satisfaction with his work, wanting to extend the contract. Lars performed his tasks with dedication and self-motivation - and demonstrated curiosity and interest as some of his driving traits. Combined with an extrovert personality that is easy to like, he was well estimated among his colleagues. Thomas Jon Jensen, MD, PhD Head of Medical Affairs, 9 March 2009

I know Lars for his work as consultant within the pharmacovigilance area in LEO Pharma for a period of 10 months. Lars has a very deep specialist knowledge about the PV area including the rules, practice and legislation. He is very dedicated in his approach of solving the tasks in the best way, at the same he is a very good colleague always supporting the good team spirit. I can give Lars my best recommendations.

Lars is a very pragmatic quality professional – he is process focused and always successful in finding the right balance between system efficiency and regulatory compliance. This approach allows Lars to work productively within all levels of the organization. He is a very positive, energetic, helpful and humorous personality and a joy to work with.

Lars is truly persevering and persistent when introduced to new challenges. He always finds solutions, even to less well defined task. Flexible and co-operative, interested, bright and committed are key words to describe Lars.

My working relations with Lars cover 8 years over the last 11 years. During these years I have experienced the dedication, enthusiasm and bright spirits Lars brings to work every day, making it so easy to work with him. I have several times worked with Lars on projects from concept to finalisation and realisation. He is a good motivator, a gentle pusher and finishes the job with an eye on agreed deadlines. He is detail oriented without losing focus on the end-product. He seems comfortable with both routine and new assignments. I'd be happy to be on Lars' project team, or have him on my project team in my future working life also.

I have had the pleasure of working with Lars for the second time. Lars was hired to prepare the PSMF: "Pharmacovigilance System Master File" for ALK to comply with the new European Pharmacovigilance legislation which was put in force by July 2012. Lars' approach to the assignment has been meticulous, structured and dedicated. He has sought and found the necessary information across functional areas within the organization. As a person, Lars undertakes an assignment, and takes it all the way to its conclusion with a constant curiosity. He is a good colleague and has a great personality and is an asset for the team spirit.

Lars er dygtig til at betræde ukendt territorium. Han er grundig og har en udpræget evne og lyst til at sætte sig ind i nyt stof og er god til at blive i en problemstilling til den er løst.

Lars is a very loyal and hard working colleague that knows his area and deliver as agreed. He is an easy going personality that also helps gluing a team together. I can give him my best recommendation and will be available for additional information if needed.

Although acting as a consultant on the sideline from 2022, Lars was employed fultime by Donor Network in 2023, to establish and lead a chain of new sperm banks (collectively under the name, Donor Network Sperm Bank). Acting as the Quality Director/Responsible Person and operational Data Protection Officer, we first really started working together on this project, when he was searching for appropriate locations for the purpose, and we soon agreed on using my clinic facilities for one such future establishment. Lars was indispensable in setting up the quality and privacy management systems, documenting procedures, negotiating with service providers, validating sites (incl. a number of satellite collection sites), passing the inspection and eventually obtaining the permit. Most of these activities were carried out by him alone.

Once starting up sperm banking activities, Lars took on the additional role as Chief Operating Officer, managing daily operations/production, incl. donor recruitment/onboarding, processing, logistics/coordination, release, compensation, ongoing risk assessment, equipment/facility issues, budgets and expenses etc.

From that point on, Lars and I were in daily contact, and we have shared many moments of laughter and frustration over various fortunate and unfortunate coincidences, unforeseen events, and challenges along the way - some exciting, others less so. We worked together for more than two years running Donor Network Sperm Bank at my site, while simultaneously obtaining permits for additional affiliate sites. For six years, I have worked with Lars in several different contexts, and I can confidently say that he is incredibly pleasant and great fun to work with, tireless in his efforts, and highly skilled at what he does. Louise Zielinski/Head of Laboratory, Donor Network Sperm Bank

Services

Expert consultancy for healthcare, pharma, biotech, and fertility sectors

Tissues/Cells & Assisted Reproduction

Specialist consultancy for organisations operating in the tissues, cells, and assisted reproduction sector, supporting regulatory compliance, quality, safety, and ethical practice across the full lifecycle of donated and clinical materials, in line with applicable legal and regulatory frameworks.

Regulatory Compliance & Authorization
Donor Management & Donor Safety
Clinical & Laboratory Governance
Quality Management Systems (QMS)
Traceability & Vigilance
Risk Management & Patient Safety
Ethics, Consent & Patient/Donor Rights
Data Protection & Information Governance
Audit, Inspection & Authority Readiness

Governance, Compliance & Quality

Support for healthcare and life science organisations in establishing and maintaining effective governance, compliance, and quality frameworks that meet regulatory, ethical, and operational requirements—while enabling consistent oversight, accountability, and operational excellence.

Regulatory & Legal Compliance
Clinical Governance
Quality Management Systems (QMS) & Continuous Improvement
Risk Management & Patient Safety
Ethics & Consent Governance
Audit, Inspection & Regulatory Assurance
Organizational Governance, Strategy & Oversight
Governance Training & Capability Development

Information Security & Privacy

Guidance on the secure, lawful, transparent, and responsible management of information and personal data. Supporting compliance with applicable legal and regulatory requirements, strengthening organisational resilience, reducing risk exposure, and maintaining trust with clients, employees, partners, and regulators.

Governance & Accountability
Legal & Regulatory Compliance
Security Risk Management
Security Controls & Assurance
Privacy Management & Individual Rights
Third-Party & Supply Chain Risk
Secure & Privacy-Centric Design
Incident Response & Resilience
Training & Culture

Tissues/Cells & Assisted Reproduction

Since 2012, I have gained extensive hands-on experience in the tissues/cells and assisted reproduction sector, working in highly regulated environments across both operational and leadership roles. My background includes positions such as Quality Director, Chief Operating Officer, Responsible Person, Data Protection Officer, and independent consultant, supporting fertility clinics and sperm banks with their regulatory, quality, and governance obligations.

I have worked across the full spectrum of activities within assisted reproduction and tissue establishments – from day-to-day operations and donor management to strategic quality systems, regulatory compliance, and authority engagement. This combination of practical operational insight and regulatory expertise allows me to translate complex requirements into clear, workable solutions tailored to each organization’s size, maturity, and risk profile.

This background enables me to support clients across the full tissues/cells and assisted reproduction lifecycle, providing structured, pragmatic, and regulator-ready services.

Regulatory Compliance & Authorization

Support to meet national/international regulatory requirements for tissues/cells, and assisted reproduction technologies (ART). Includes regulatory gap analysis/compliance mapping, application process/licensing, new affiliates/collection sites, interaction with competent authorities and acting as Responsible Person (GxP, ICH, EDQM, ESHRE, ESHG, WHO etc.).

Donor Management & Donor Safety

Frameworks to protect donors and ensure ethical and safe donation practices. Includes donor eligibility criteria, screening processes, risk assessment, compensation policies, follow-up procedures, release and acting as COO – with full responsibility for operations, production and the donor value chain.

Clinical & Laboratory Governance

Structures to ensure safe, effective, and evidence-based clinical and laboratory practice. Includes equipment oversight, validation, performance monitoring, providing expertise and guidance on safety and precautionary measures, monitoring threats from infectious diseases (ECDC, CDC, WHO etc.), and acting as COO – with full responsibility for operations/production (ISO 15189/23162 etc.).

Quality Management Systems (QMS)

Design, implementation, and maintenance of QMS aligned with sector standards and regulations.

Includes SOPs, document management (DMDC, Novax, D4 Infonet etc.), change management, CAPA, continuous improvement (digitation, automation, etc.) and integration of standards and sector-specific guidance (ISO 900X, EFQM etc.).

Traceability & Vigilance

Systems to ensure full traceability from donor to recipient and beyond. Includes coding and labeling, record retention, management of adverse reactions/events, deviations, complaints/claims, root cause/trend analysis, CAPA planning, reporting obligations, recall procedures, and vigilance systems.

Risk Management & Patient Safety

Risk-based approaches to protect patients, donors, and future children (procurement, cross-contamination, mix-ups, traceability etc.). Includes risk assessments (ISO 31000, FMEA etc.), critical process analysis, incident management, and preventive controls.

Ethics, Consent & Patient/Dono/Donor Child Rights

Governance of ethical decision-making and protection of individual rights. Includes informed consent processes, embryo disposition policies, donor and child rights considerations, and ethical oversight structures.

Data Protection & Information Governance

Compliance with data protection and confidentiality requirements for sensitive reproductive and genetic data. Includes GDPR alignment, access control, data retention, traceability records, and staff training (see separate Service).

Audit, Inspection & Authority Readiness

Preparation for inspections, audits, and regulatory reviews. Includes internal/stakeholder audits, inspection readiness assessments, CAPA planning, and post-inspection follow-up.

Governance, Compliance & Quality

Drawing on a solid background in regulated industries and government authorities – including pharmaceuticals, fertility, and specialist medical practices – I support organisations in navigating complex regulatory, governance, and quality landscapes. My experience spans product and service quality, patient and consumer safety, business ethics, and scientific research, helping clients meet both regulatory requirements and organisational objectives.

With extensive hands-on experience across a wide range of products and services, I bring deep expertise in quality management and a thorough understanding of the regulatory and ethical foundations of governance, compliance, and quality. I offer a practical, structured, and implementation-focused approach, supporting organisations in operating confidently, efficiently, and in full alignment with applicable regulations and quality standards.

As a subject matter expert, I provide guidance, training, project leadership, and oversight in complex, multi-stakeholder environments – ensuring that governance, compliance, and quality frameworks are not only designed, but effectively embedded and sustained in practice. This expertise enables me to support clients with a broad range of governance, compliance, and quality services, including:

Regulatory & Legal Compliance

Ensuring alignment with applicable laws, regulations, and sector-specific requirements. Includes mapping and interpreting regulatory frameworks, licensing and accreditation support, compliance gap assessments, and readiness for audits and inspections (GxP, ICH, EDQM, WHO, ESHRE, ESHG, ISPE, PIC/S, ISO etc.).

Clinical Governance

Establishing frameworks to maintain and continuously improve clinical standards and outcomes. Includes development of clinical policies and procedures, performance monitoring, evidence-based practice frameworks, accountability structures, and staff guidance and training. Quality principles are integrated into clinical processes to ensure consistent standards and safe, high-quality patient care.

Quality Management Systems (QMS) & Continuous Improvement

Design and implementation of structured quality and management systems that support consistent performance, compliance, and continuous improvement. Includes SOP development, document control, change management, CAPA processes, and initiatives such as digitisation and process optimisation (e.g. ISO 9001/14001/45001 and EMAS).

Risk Management & Patient Safety

Identification, assessment, and mitigation of clinical and operational risks. Includes establishment of risk management frameworks, risk registers, incident reporting systems, root cause analysis, safety culture development, emergency preparedness, and staff training (GxP, ICH, EDQM, FMEA, ISO 31000/22301 etc.).

Ethics & Consent Governance

Ensuring ethical practice and protection of patient, consumer, and donor rights. Includes informed consent processes, ethical review structures, rights protection frameworks, conflict of interest management, and organisational guidance in areas such as clinical research and emerging technologies. Quality principles underpin all ethics and consent procedures to maintain integrity and accountability.

Audit, Inspection & Regulatory Assurance

Preparation for and management of audits and inspections. Includes internal and external audits, inspection readiness, CAPA planning, performance monitoring and reporting, regulatory follow-up, and training to support confident engagement with authorities. Quality-focused audit and assurance processes help maintain consistent standards across the organisation.

Organizational Governance, Strategy & Oversight

Establishing clear governance structures that support effective decision-making, accountability, and strategic alignment. Includes governance frameworks, roles and responsibilities, policies and procedures, stakeholder management, leadership reporting, and alignment of governance, compliance, and quality activities with organisational objectives.

Information Security & Privacy

With extensive experience as a Data Privacy Specialist/Data Protection Officer (DPO), I have supported organisations across the fertility sector, pharmaceutical industry, health-tech and consultancy environments in managing privacy, data protection, and information security requirements across multiple jurisdictions.

I have led end-to-end privacy and information security programs in highly regulated and operationally complex settings involving large volumes of sensitive and special-category personal data, confidential business information, multiple data subject categories, extensive vendor and processor networks, and intricate processing and information management activities. My experience spans tissue and cell donation, assisted reproduction, pharmaceutical development/surveillance, healthcare platforms and scientific/clinical research.

I bring a practical, business-aware approach that integrates regulatory expertise with risk management, governance, and operational resilience. My focus is on delivering clear, proportionate, and actionable advice, that enables organisations to meet compliance obligations, strengthen security posture, manage risk effectively, and build sustainable trust.

Based on this experience, LHR Consult offers tailored information security and privacy services designed for organisations operating in regulated, high-risk, and data-intensive environments.

Governance & Accountability

Establishing effective governance structures to manage information security and privacy strategically and sustainably. Includes governance frameworks aligned with recognised standards (ISO 2700X/ 27701/29100, CIS, NIST etc.), board-level reporting and oversight structures, role definition and accountability (DPO, Information Security Lead, EU Representative), Records of Processing Activities (RoPA), policy ownership and lifecycle management, and structured breach and incident governance processes.

Legal & Regulatory Compliance

Ensuring alignment with applicable data protection, information security, and sector-specific legal requirements. Includes GDPR and local data protection law compliance, sector-specific regulatory requirements (healthcare, scientific research, labour law, marketing, financial record-keeping), lawful basis and consent assessments, regulatory gap analysis, compliance reviews, documentation support, and regulatory readiness across jurisdictions.

Security Risk Management

Identifying, assessing, and mitigating information security and privacy risks before they materialise. Includes enterprise security risk assessments, privacy risk assessments, Data Protection Impact Assessments (DPIAs), high-risk processing reviews, threat and vulnerability considerations, risk treatment planning, and alignment with recognised risk management methodologies.

Security Controls & Assurance

Strengthening organisational safeguards to protect information assets effectively. Includes security control gap analysis, evaluation of technical and organisational measures, access control and data classification frameworks, retention and deletion controls, assurance reviews, and support in preparing for certification or regulatory scrutiny where applicable.

Privacy Management & Individual Rights

Embedding structured privacy management processes and enabling lawful, effective handling of individual rights. Includes development of privacy frameworks, transparency and notice requirements, DSAR processes, right to erasure, rectification and objection handling, response workflows and templates, timeframe monitoring, and support for complex or high-risk rights requests.

Third-Party & Supply Chain Risk

Managing privacy and security risks arising from vendors, processors, and data-sharing arrangements. Includes vendor due diligence and risk assessments, data processing agreements (DPAs), joint controller and data-sharing arrangements, international data transfer assessments, contractual security provisions, and ongoing supplier risk monitoring and oversight.

Secure & Privacy-Centric Design

Embedding security and privacy principles into systems, projects, and organisational change. Includes privacy-by-design and security-by-design advisory, new system and technology reviews, data minimisation and purpose limitation guidance, secure development lifecycle input, technical and organisational control recommendations, and support for transformation initiatives and new product development.

Incident Response & Resilience

Preparing for, responding to, and learning from security and data protection incidents. Includes incident response framework design, breach identification and assessment processes, regulatory notification support, communications guidance, post-incident remediation planning, lessons-learned integration, and resilience strengthening measures.

About

I am a biochemist by training, with a career built at the intersection of science, regulation, and trust. After completing my Master’s degree at the University of Copenhagen, I have worked in full-time roles across drug development, patient safety, regulatory affairs, and compliance in both industry and government, including positions at leading pharmaceutical companies, contract research organisations and the Danish Medicines Agency.

In 2012, I moved into the fertility sector, where I spent eight years in senior, hands-on roles supporting the growth of a rapidly expanding Danish sperm bank into a leading European organisation. During this period, I was responsible for managing and developing quality, governance, and data protection activities, establishing robust frameworks that met complex international regulatory requirements while enabling innovation and scalability.

In 2020, I founded LHR Consult to bring this practical, real-world experience to other organisations. Since then, I have combined consultancy work with senior operational and leadership roles in the fertility and information security space, including supporting the launch of new regulated businesses from the ground up.

My approach is collaborative, pragmatic, and focused on helping organisations navigate complexity with confidence.

I thrive in dynamic, international environments characterized by shifting and competing priorities, a wide range of tasks, and broad stakeholder engagement. With a strong attention to detail, accuracy, and compliance, I approach challenges across departments, disciplines, and solutions with a holistic mindset. At the same time, I advocate for balance and recognize the importance of pragmatic, action-oriented solutions in this context.

I am a good listener, coach, and motivator, and I collaborate easily and effortlessly across professional groups. My strong communication skills enable me to engage at all levels, build sustainable and trust-based relationships, and convey complex issues in a professional and easily understandable manner.

With a strategic and business-oriented approach, I am experienced in meeting the needs and expectations of stakeholders, delivering results, and providing high-quality solutions – a key prerequisite for customer satisfaction and loyalty, as well as the organization’s long-term success.

Post-Educational Training & Expertise

I hold multiple post-educational certifications spanning GxP, quality management, risk, auditing, project management, medical genetics, and business continuity, reflecting a broad and rigorous professional foundation. I regularly serve as a subject matter expert, providing strategic advisory services, specialist training, and thought leadership across complex quality, compliance, and governance initiatives.

Within the fertility sector, I have extensive experience collaborating closely with fertility clinics, sperm banks, laboratories, accreditation bodies, regulatory authorities, and ethics committees. This hands-on engagement enables me to bridge regulatory expectations with clinical and operational realities. I also contribute actively to the advancement of the field through lectures, webinars, and professional activities within national and international fertility societies and organisations (e.g. IFFS, SRF, ESHRE, EFS, NFS, and DFS).

In the area of data protection and privacy, I hold advanced and internationally recognised certifications, including CIPP/E, CIPM, IAPP Fellow of Information Privacy, and GDPR Master Class. This formal expertise is complemented by substantial practical experience in privacy governance, risk, and compliance (GRC) and the implementation and use of enabling technologies, including OneTrust. I have collaborated closely with leading data protection practitioners at top-tier law firms and maintain active participation in professional forums and knowledge-sharing platforms (IAPP, OT DataGuidance, DPO Association of Denmark etc.), ensuring continuous alignment with regulatory developments and best practices.

This integrated and cross disciplinary expertise allows me to deliver consultancy services that are pragmatic, compliant, and strategically aligned, supporting organisations in navigating complex regulatory landscapes while sustaining operational excellence, stakeholder confidence, and trust.

Projects Completed to Date

Establishing, reviewing, and managing quality management systems, including processes and controlled documentation, supported by platforms such as D4Infonet, DMDC, and Novax, to ensure regulatory compliance and operational consistency.
Conducting gap analyses across quality, privacy, and regulatory content, including reviews of websites and other public-facing materials, to identify compliance risks and define clear remediation actions.

Managing contracts and third-party engagements, supporting the selection, onboarding, and oversight of service providers to ensure alignment with regulatory, quality, and data protection requirements.

Planning and executing internal audits and inspection readiness activities, including preparation for regulatory inspections, coordination during inspections, and follow-up on findings to achieve successful outcomes.

Supporting regulatory approvals and permit management, including applications for new permits and variations to existing approvals, ensuring timely and compliant submissions.

Providing senior quality and compliance oversight for fertility clinics, acting as Responsible Person to support safe operations, regulatory compliance, and continuous improvement.
Providing strategic and operational advice to sperm bank start-ups, covering approval pathways, regulatory strategy, quality system design, and legal requirements from initial concept through operational readiness.

Advising on regulatory, ethical, and data protection requirements related to offering polygenic risk scores as a service, including assessment of legal frameworks, risk considerations, and compliance obligations.
Establishing electronic document management systems (EDMS) and implementing structured change control and deviation management processes within biotech organisations to support compliance, traceability, and continuous improvement.
Conducting privacy gap and maturity assessments and developing GDPR-aligned privacy documentation for organisations in the public healthcare sector, biotech companies, and fertility clinics.
Designing and implementing comprehensive privacy and information security programmes, aligned with international standards, providing ongoing oversight and advisory support, and acting ad Data Protection Officer within pharmaceutical organisations.
Supporting the implementation of ISO 27001-aligned information security management systems within pharmaceutical consultancies, strengthening governance, risk management, and regulatory assurance.
Advising biotech organisations on medical device regulation, including MDR requirements and preparation for ISO 13485 certification, from regulatory strategy through implementation support.

Reach out!

Get in touch to discuss

+45 2390 5889

Contact@lhr-consult.dk

LHR Consult, Copenhagen/Denmark

CVR-no. (VAT): 3415 9726