Manufacturing and quality services
- Pragmatic and experienced specialist QPs (qualified persons) to
- provide EU QP certification for clinical trials, and
- review data for regulatory acceptability, compile IMPDs and advise on
development strategy
- auditing of manufacturing sites for compliance with GMP
- Location of high-quality GMP units, particularly those able to produce special batch
sizes
- Liaison with clinical trials supplies management units, importers and distributors
- Management of import and QP release of investigational and marketed drugs in the EU
