- 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