Services
We offer the following services to the pharmaceutical sector:
- Quality Overall Summary and Quality Expert Report Preparation
- Dossier review, gap analysis and remediation advice
- Dossier lifecycle maintenance
- Clinical trial applications
- Preparation and co-ordination of National, Mutual Recognition (MRP) and Decentralised (DCP) applications
- Project management from development through to product launch
- Acting as MAH
- Regulatory strategy
- Liaison and collaboration with regulatory agencies
- Onsite placement
- Training