LHR Consult offers legal advice, quality management and administration of information security/ data privacy (GDPR etc.) within the healthcare business, e.g. pharma/biotec (clinical drug develop-ment, pharmacovigilance, 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

  • Advicing on quality, safety and ethical aspects of tissue/cell activities, e.g. procurement, testing, processing, preservation/storage, coding, matching, distribution, import/export, ART and research.
  • Advicing on donor management, screening, egg/ sperm quality, aseptic/sterile production, lab equip-ment (IQ/OQ/PQ), PPE etc. (GxP, OECD, WHO etc.).
  • Advicing on the upstart of new tissue/donation sites.
  • Acting as Responsible Person.

Privacy and data protection

  • Mapping data inventories, systems, flows and requirements for global markets (EU, UK, US etc.).
  • Privacy risk assessing of all business areas (PIA/DPIA) using appropriate risk models.
  • Implementing and operating privacy programs in alignment with ISO 2700X/2770X/29100 etc.
  • Providing privacy program awareness and training.
  • Acting as Chief Privacy Officer, Data Protection Officer, EU Representative etc.

Quality management

  • Preparing and maintaining frameworks and documentation (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.
This website uses cookies. By continuing browsing on the site you agree the use of cookies