LHR Consult offers legal advice, quality management and administration of data protection/GDPR within the fertility/healthcare business (tissues and cells, assisted reproduction etc.), life science and other academic disciplines of the public/private sector.

LHR Consult

Tissues and cells

  • Providing legal advice on tissues and cells activities, patient rights, healthcare professionals’ duties/rights, authorization, record keeping, reporting obligations etc.
  • Acting as Responsible Person (Tissue Order §4/5).
  • Preparing, implementing and maintaining quality documentation/management systems (GxP, ICH, ISO 2700X/900X etc.).
  • Preparing and executing internal/external audits (ISO 19011).

Data protection

  • Preparing, implementing and maintenance of ISMS/GDPR compliance-package (ISO 2700X/ 27701/29100).
  • Providing legal advice and consultation on data protection, the GDPR, special law, information-/IT- and cyber security, ePrivacy, data ethics, digital responsibility etc.
  • Acting as Data Protection Officer/DPO (GDPR Art 37).
  • Managing of data subject rights, requests, complaints etc.

Quality management

  • Preparing, implementing and maintaining quality documentation/management systems (GxP, ICH, ISO 2700X/900X etc.).
  • Planning, implementing and driving the processes of risk management (EU/GxP, ICH, ISO 27005/31000).
  • Registrating, assessing (root cause, CAPAs etc.) and reporting of incidents, reactions, deviations, complaints etc. (EU/GxP, ISO 13485 etc).
  • Acting as Quality Responsible/quality point of contact.
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