LHR Consult offers quality management, administration of information security/data privacy, preparation of documentation and legal advice within the healthcare business, e.g. tissues & cells, pharma and biotech - as well as other academic disciplines of the public/private sector.

LHR Consult

Tissues and cells

  • Advising on legal requirements, quality, safety and ethics related to tissue establishment activities (GxP, OECD, WHO, EDQM mv.).
  • Advising on egg/sperm donation, screening and risk assessment, adverse reactions etc.
  • Upstart of tissue establishments (submissions, reporting, inspection etc.).
  • Preparation of all documentation, quality management and acting as Responsible Person.

Privacy and data protection

  • Preparing gap-/maturity analyses, risk assessments, audits and other evaluation.
  • Mapping of data inventories, systems, data flows and requirements for global markets (EU, UK, US etc.).
  • Implementing and operating information security/ privacy programs in alignment with international standards (ISO, NIST etc.).
  • Acting as Chief Privacy Officer, Data Protection Officer, EU Representative etc.

Quality management

  • Preparing and maintaining frameworks and docu-mentation (ISO 900X, GxP, OECD, WHO etc.).
  • Establishing, monitoring and analyzing metrics/indi-cators (trending, ROI, resiliency and maturity).
  • Preparing and executing internal/vendor audits.
  • Managing inquiries, deviations/non-conformities, complaints and incidents (root causes, corrective actions, change control, reporting etc.).
  • Acting as Quality Responsible.
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