Clinical Trial Support Services

Our extensive regulatory intelligence combined with our operational expertise ensures that your clinical trial is aligned with the latest regulatory agency developments. Our services include:

1. Multinational and global submissions (IMPD/CTA/IND and global equivalents)
2. EU Voluntary Harmonisation Procedure (VHP) support
3. Legal representative and local sponsor services
4. UK agent support for INDs and other agency interactions
5. New EU Clinical Trial Regulation No 536/2014 consultancy
6. Preparation of investigator brochures

In addition, we provide full strategic and operational regulatory support, including:

1. Global regulatory intelligence
2. EU and UK Orphan drug designation
3. Paediatric investigational plans
4. Due diligence for marketing authorisation acquisitions and gap analysis
5. Risk management and mitigation strategy
6. Cross-functional project plans including budget and schedule management