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Regulatory affairs

Quality Assurance

DAYFOTOGRAFI-PR2022-0202

Experienced and knowledgable support whenever needed

We work together to find flexible solutions and help you meet your deadlines, all hands-on deck when required. We can offer a broad range of different consultant solutions, from external consultants that work full time at our customers but also in- house consultants that work part time at our customers. We have both junior and senior consultants in our team to match your demands.


All our consultants has a long background in the pharmaceutical industry or as inspector from the medical agency.


We work within GMP, GDP, GLP as well as GCP.


DAYFOTOGRAFI-PR2022-0533 1

SERVICES

  • QP/RP full time or part time. Complaint management
  • QMS implementation and improvements. Audits - GMP/GDP/GCP/ ISO13485
  • Audits - internal, supplier, joint audits, mock-audits
  • Inspections 
  • Batch release
  • Risk assessments
  • Qualification and validation
  • GAP-analysis and CAPA plans
  • Life cycle management, e.g. change control, PQR/APR, complaints, deviations
  • Due Diligence process
  • Quality agreements
  • Training programs, GMP/GDP/GCP/ ISO13485

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