Non-EU small biotech company planning to include EU sites in a Phase II study and building out an EU regulatory pathway to MAA .
Non-EU small biotech company planning to include EU sites in a Phase II study and building out an EU regulatory pathway to MAA .
1 PagesSuite 2, Ground Floor, Field House, Station Approach, Harlow, Essex CM20 2FB T +44 (0)203 911 9410 F +44 (0)1279 418 964 diamondpharmaservices.com DEVELOPMENT STAGE REGULATORY SUPPORT The Regulatory Development Department at Diamond Pharma Services has extensive experience in assisting companies to navigate through clinical development. We provide a wide range of services including: • Regulatory GAP analysis and development plans • National and EMA scientific advice meetings • Prime applications • Orphan designation applications • Paediatric investigation plans • CTA • MAA • eCTD submissions We are specialists in providing bespoke cover to companies either via the provision of dedicated full time equivalent coverage, or ad hoc support. The team have extensive experience in worki
