LHR Consult

When Quality Matters

LHR Consult provides practical consultancy in quality management, governance, regulatory compliance, information security and data privacy.

I work with organisations in regulated, complex or quality-critical environments, translating regulatory requirements and organisational objectives into clear, sustainable solutions.

What Colleagues/Clients Say

Expertise, integrity and a collaborative approach

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.

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.

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 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 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.

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 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.

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.

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

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’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.

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.

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.

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

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.

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 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.

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.

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.

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.

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.

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.

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.

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!

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 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.

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.

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.

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.

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 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 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

Support that fits your needs – from focused assignments to long-term collaboration

Gamete Banking & Assisted Reproduction

Supporting organisations working with reproductive material and assisted reproduction, with a focus on safe, compliant and well-functioning operations across clinical, laboratory and organisational settings.

Regulatory Governance, Compliance & Authorisation
Quality Management, Documentation & Traceability
Assisted Reproduction & Clinical Governance
Laboratory Processes, Qualification, Validation & Safety
Processing, Preservation, Cryopreservation, Storage & Logistics
Donor, Recipient & Family Services, Safety & Rights
Vigilance, Non-conformity, Audit & Operational Leadership

Information Security & Data Privacy

Supporting organisations in protecting information and personal data, with a focus on responsible data use, effective governance and proportionate approaches to security, privacy and risk management.

Governance, Legal & Regulatory Compliance
Security & Privacy by Design
Information Security Management, Risk & Controls
Privacy Management, Privacy Risk & Individual Rights
Third-party & Supply Chain Assurance
Incident/Breach Management, Response & Org. Resilience
Audit, Training & Responsible Functions

Quality, Governance & Compliance

Supporting organisations in creating clear and effective approaches to quality, governance and compliance, with a focus on good practices, accountability and sustainable ways of working across the organisation.

Governance, Regulatory & Legal Compliance
QMS, Documentation & Continual Improvement
Operational Excellence, Validation & Performance
Risk Management & Operational Resilience
Ethics, Good Governance & Stakeholder Accountability
Vigilance, Incident & Non-conformity Management
Audit, Inspection, Training & Quality Leadership

Gamete Banking & Assisted Reproduction

Since 2012, I have worked with organisations in the tissues/cells and assisted reproduction sector, including fertility clinics and sperm banks, in highly regulated environments and across both operational and leadership roles.

My experience covers day-to-day operations, donor management, quality management, regulatory compliance, governance, data protection and engagement with authorities. I have held roles including Quality Director, Chief Operating Officer, Responsible Person and Data Protection Officer, as well as working as an independent consultant.

I support organisations in translating regulatory requirements and organisational objectives into clear, workable approaches that fit their activities, size, maturity and risk profile. This includes supporting both established operations and organisations developing or implementing new processes, systems or facilities.

My work covers the full gamete banking and assisted reproduction lifecycle, including:

Regulatory Governance, Compliance & Authorisation

Supporting sperm and egg banks, fertility clinics and related organisations with regulatory governance, authorisation, licensing, legal and ethical compliance, regulatory monitoring and implementation of applicable requirements, including the EU SoHO Regulation, national requirements and relevant guidelines (EDQM, ESHG, ESHRE etc.).

Quality Management, Documentation & Traceability

Designing, implementing and improving quality management systems, controlled documentation, journal and record management, data integrity and end-to-end traceability across fertility and reproductive medicine operations. Includes digital quality and journal systems and tools, including DMDC and Novax, supporting compliance, efficiency, documentation and continual improvement.

Assisted Reproduction, Clinical & Laboratory Governance

Supporting assisted reproduction technologies (ART), including IVF and ICSI, as well as sperm, oocyte and embryo donation and fertility preservation. Includes clinical and laboratory governance and the safe management of laboratory processes throughout collection, processing, quality assessment, preservation and reproductive use.

Laboratory Processes, Qualification, Validation & Safety

Supporting the qualification and validation of facilities, equipment, systems and laboratory processes, including process validation, equipment qualification, safety and precautionary measures, contamination control, environmental and personnel safety, and quality assurance in accordance with applicable requirements and relevant standards and guidance incl. requirements where relevant (WHO, ISO 15189/ISO 23162 etc.).

Processing, Preservation, Cryopreservation, Storage & Logistics

Managing the safe, compliant and traceable handling of sperm, oocytes and embryos across collection, processing, preservation, cryopreservation, storage, quality assessment, release, distribution, import/export and logistics. Includes inventory management, identification, chain of custody, transportation and maintenance of the required conditions throughout the process.

Donor, Recipient & Family Services, Safety & Rights

Supporting the full donor, recipient and family journey, including donor recruitment, screening, eligibility, informed consent, donor rights, recipient considerations, donor matching, genetic counselling, fertility preservation, family management and the protection of donor, recipient and offspring safety and rights.

Vigilance, Non-conformity, Audit & Operational Leadership

Establishing and improving systems for vigilance, adverse events and reactions, deviations, complaints, non-conformities, CAPA, recalls and emerging safety risks, including relevant infectious disease and genetic monitoring. Preparing organisations for audits, inspections and regulatory review, supporting regulatory readiness and establishing new sperm banks, collection sites and fertility facilities. Includes operational leadership and acting as Chief Operating Officer (COO), Responsible Person or other designated responsible function where required.

Information Security & Data Privacy

Prior to the implementation of the GDPR in 2018, I had already gained experience in information security and data protection. Since then, I have supported organisations across healthcare, fertility and pharmaceutical industries, scientific research, insurance and technology, including healthcare platforms, in managing information and personal data securely across multiple jurisdictions.

My experience includes leading information security and privacy programmes (ISMS/PIMS) in highly regulated and operationally complex environments involving sensitive and special-category personal data, confidential business information, multiple data subject categories, extensive vendor and processor networks, and complex processing and information management activities.

I help organisations translate legal, regulatory and business requirements into clear, proportionate and workable approaches to governance, risk management, security, privacy and organisational resilience. My focus is on solutions that are appropriate to the organisation, its activities and its risk profile.

My work covers the full information security and data privacy lifecycle, including:

Governance, Legal & Regulatory Compliance

Supporting organisations with information security and data protection governance, legal and regulatory compliance and risk management, including GDPR, NIS2, DORA, CRA, CER and sector-specific legal and regulatory requirements.

Security & Privacy by Design

Embedding Security by Design and Privacy by Design into systems, products, services and business processes (SaaS/SaMD, cloud, AI etc.), enabling organisations to identify and manage information security and privacy risks throughout the lifecycle of solutions and services.

Information Security Management, Risk & Controls

Privacy Management, Risk & Individual Rights

Establishing and improving privacy management and accountability, including ISO/IEC 27701, Records of Processing Activities, Data Protection Impact Assessments (DPIAs), privacy documentation, privacy risk assessments and processes for safeguarding and exercising individual rights.

Third-party & Supply Chain Assurance

Managing information security and privacy risks across suppliers, processors, SaaS, cloud services and other third parties, including due diligence, contractual requirements, Data Processing Agreements, Standard Contractual Clauses, Transfer Impact Assessments, supplier audits and ongoing assurance.

Incident Management, Response & Organisational Resilience

Preparing for, responding to and learning from information security incidents and personal data breaches, including detection, investigation, containment, notification and reporting, corrective actions, recovery, lessons learned and organisational resilience.

Audit, Training & Responsible Functions

Preparing organisations for audits, inspections, certification and regulatory review, while developing security and privacy awareness, competence and organisational capability. Includes supporting or acting as Data Protection Officer (DPO), Privacy Responsible or EU Representative where required.

Quality, Governance & Compliance

I work with organisations operating in regulated, complex or quality-critical environments, including pharmaceuticals, healthcare, fertility, insurance, technology and public authorities. My experience covers quality management, regulatory and legal compliance, governance, product and service quality, patient and consumer safety, business ethics and scientific research.

I support organisations in translating regulatory requirements and organisational objectives into clear, workable frameworks and processes. This includes quality and management systems, documentation, risk management, operational performance, validation, compliance, governance and continual improvement, with approaches adapted to the organisation, its activities and risk profile.

I also provide guidance, training, project leadership and support in complex, multi-stakeholder environments, helping organisations establish, implement and maintain effective governance, compliance and quality practices.

My work covers the full quality, governance and compliance lifecycle, including:

Governance, Regulatory & Legal Compliance

Supporting organisations in navigating regulatory and legal requirements across regulated and quality-critical industries (e.g. GxP), while establishing effective governance, accountability, compliance frameworks and risk-based approaches to regulatory requirements. Experienced in working with document management systems (D4 Infonet, SarePoint etc.), electronic medical journals (DMDC, Novax etc.).

Quality & Management Systems, Documentation & Continual Improvement

Designing, implementing and improving quality and management systems, controlled documentation, processes and organisational practices aligned with relevant standards and regulatory requirements (ISO 9001, EFQM etc.), while supporting digitalisation through automation, data-driven decision-making, AI, SaaS and cloud computing.

Operational Excellence, Validation & Performance

Improving operational performance through process optimisation, validation and qualification, performance management and continual improvement across facilities, equipment, laboratories, systems and operational processes, applying risk-based and evidence-based approaches where appropriate.

Risk Management & Operational Resilience

Identifying, assessing, controlling and monitoring quality, compliance and operational risks using structured approaches, with focus on resilience, preparedness, business continuity and risk-based decision-making.

Ethics, Good Governance & Stakeholder Accountability

Embedding ethical principles, Good Governance, accountability and responsible decision-making into organisational structures and operations, including informed consent, stakeholder rights and strengthening ESH accountability where relevant.

Vigilance, Incident & Non-conformity Management

Establishing and managing systems for incidents, deviations, non-conformities and quality or safety signals through vigilance, investigation, root cause analysis, CAPA, trend analysis, effectiveness monitoring and regulatory reporting, supporting compliance and continual improvement.

Audit, Inspection, Training & Quality Leadership

Preparing organisations for audits, inspections, certification and regulatory review, while developing organisational capability, competence and quality culture. Includes executive support and acting as Quality Responsible, Operations Responsible, Production Responsible or other designated responsible function where required.

About

In 2012, I moved into the fertility sector, where I spent eight years in senior, hands-on roles supporting the growth and development of a rapidly expanding Danish sperm bank with operations across Europe and internationally. During this period, I worked with quality, governance and data protection, while integrating Good Governance principles, including ESH, to strengthen ethics, transparency, accountability, compliance, sustainability and stakeholder engagement.

In 2020, I founded my own consultancy, LHR Consult, and have since combined consultancy work with senior, hands-on roles across fertility and other regulated sectors, including biotech, health tech, insurance and public health.

My approach is collaborative, pragmatic, and focused on helping organisations navigate complexity with confidence. I bring a strategic and business-aware perspective to my work, with a focus on understanding what an organisation needs and helping turn that into clear and sustainable ways of working.

I am ambitious, determined and proactive, with a strong sense of responsibility

for getting things done, also when challenges are complex. I work in a structured and detail-oriented way and take pride in delivering well-considered, high-quality solutions. I am a good listener and enjoy motivating and collaborating with people across professional groups, while making complex issues easier to understand and work with.

I thrive in dynamic environments with extensive cross-organisational collaboration, where I can work across a broad range of tasks and stakeholders. With an eye for the strategic, tactical and operational levels, I take a holistic view across departments, solutions and areas of expertise, helping create coherence, efficiency and trust in organisations with changing and competing priorities.

I am open, straightforward and enjoy building trusting relationships. I believe that a positive and respectful working environment is important for good collaboration and long-term success, and I value contributing to a culture where people feel heard, supported and able to work well together.

Post-Educational Training & Expertise

From my time in the pharmaceutical industry and at the Danish Medicines Agency, I have built a solid professional foundation through multiple post-educational certifications across GxP/project/risk/quality management, auditing, pharmacovigilance, and drug development, along with frequent visits to the European Medicines Agency headquarters. This foundation not only allows me to navigate effectively between industry and regulatory requirements, but also underpins my work in the fertility sector and in information security/data privacy.

Building on this foundation, I have gained extensive hands-on experience in the fertility sector, working closely with clinics, sperm banks, laboratories, accreditation bodies, regulatory authorities, and ethics committees. Supported by a laboratory background and a certification in medical genetics from the Faculty of Health, University of Copenhagen, I bring a strong understanding of clinical, genetic, and technical processes, enabling me to translate regulatory requirements into practical operational solutions. I stay up to date through national and international authorities and fertility societies/ organisations (e.g. IFFS, SRF, ESHRE, EFS, NFS and DFS).

Complementing this domain experience, I specialise in information security and data privacy, with internationally recognised certifications including CIPP/E, CIPM, IAPP Fellow of Information Privacy, OneTrust Fellow of Privacy Technology, as well as a GDPR Master Class.

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 (e.g. IAPP, OneTrust DataGuidance, and the DPO Association of Denmark), 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 and sustaining operational excellence, stakeholder confidence, and trust. I create value through knowledge, simplicity, and innovation (data-driven approaches, automation, AI etc.) by enhancing quality, efficiency, and compliance.

Projects Completed to Date

Establishing, reviewing, and managing quality management systems, processes and documentation (D4Infonet, DMDC, Novax etc.) in a sperm bank/fertility clinics, to ensure regulatory compliance and operational consistency.
Conducting gap analyses across quality, privacy, and regulatory content, incl. reviews of websites and other public-facing materials in a sperm bank start-up/fertility clinics, to identify compliance risks and define clear remediation actions.
Managing contracts/third-party engagements and supporting the selection, onboarding, and oversight of service providers in a fertility clinic, to ensure alignment with regulatory, quality, and data protection requirements.
Planning and executing internal audits and inspection readiness activities, incl. preparation for regulatory inspection, coordination during inspections, and follow-up on findings in fertility clinics.
Supporting regulatory approvals and permit management, incl. applications for new permits and variations to existing approvals in fertility clinic, to ensure timely and compliant submissions.
Providing quality and compliance oversight to a fertility clinic, acting as Responsible Person to support safe operations, regulatory compliance, and continuous improvement.
Providing strategic and operational advice to a sperm bank start-up, 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 (sperm donation/fertility treatment), incl. assessment of legal frameworks, risk considerations, and compliance obligations.
Establishing electronic document management system (EDMS) and implementing structured change control and deviation management processes in a biotech company, to support compliance, traceability, and continuous improvement.
Conducting privacy gap/maturity assessments and developing GDPR-aligned privacy documentation in a biotech company and in public healthcare.
Designing and implementing a privacy framework aligned with international standards, providing ongoing oversight, advisory support and acting as Data Protection Officer in a pharmaceutical company.
Supporting the implementation of an ISO 27001-aligned information security management system in a pharmaceutical consultancy, strengthening governance, risk management, and regulatory assurance.
Advising a biotech company on the medical device regulation (MDR), incl. requirements and preparation for ISO 13485-certification - from regulatory strategy through implementation support.
Advising on- and developing policies related to data privacy management, whistleblowing frameworks, and other compliance processes for a logistics company.

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Get in touch to discuss

+45 2390 5889

Contact@lhr-consult.dk

LHR Consult, Copenhagen/Denmark

CVR-no. (VAT): 3415 9726