Pharm Quality System

  • GMP Due Diligence
  • Supplier qualifications/on-site GMP audits
  • Quality Technical Agreements
  • Building new Pharm Quality Systems (PQS)
  • Gap assessments and Improvements to existing PQS
  • Data Integrity
  • Support in preparation to routine FDA or IGJ inspections as well as GMP inspections of the Russian Authorities including support during inspections (incl. translation services from Russian into English or Dutch)
  • QP APIs/key intermediates GMP declarations for RA submissions