LHR Consult offers quality management, administration of information security/data privacy (ISO, GDPR etc.) and legal advice within the healthcare business, e.g. pharma/biotech (GxP etc.) and tissues & cells (fertility/assisted reproduction, stem cells, scientific research etc.) - as well as other academic disciplines of the public/private sector.

LHR Consult

Tissues and cells

  • General advising on tissue establishment requirements, upstart, submissions, reporting, inspections etc.
  • Advising on quality, safety and ethical aspects of tissue/cell activities, e.g. procurement, aseptic processing, cryopreservation, distribution, research and use of ART (GxP, OECD, WHO etc.).
  • Advising on sperm/egg donor management - enrolment, screening, qualification criteria etc.
  • 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 ISO 2700X/ 2770X/29100 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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