Pharm Quality System for IMP(s)

  • Creation and improvement of Pharmaceutical Quality System (PQS) for IMPs, including Document Management System and Change Control
  • GMP due diligence and risk assessments on CM(D)Os for development purposes (testing, validation and manufacture)
  • On-site GMP audits at R&D labs/manufacture facilities for APIs or IMPs
  • Support in obtaining GMP Certificates for testing/manufacture/import and/or packaging activities of IMPs
  • Qualification of R&D lab equipment