Our expertise in international regulatory affairs will help you navigate any regulatory hurdle, leading to resolution through negotiation.
- Regulatory Strategies
- Orphan Drug/Medicinal Product Designation (ODD, OMPD) applications
- Scientific Advice/Protocol Assistance briefing packages
- Paediatric Investigational Plans (PIP)
- Background documents for FDA Type C, Pre-IND and Pre-NDA meetings
- Preparation for and participation in meetings with Competent Authorities
- Accelerated Pathways designation applications
- Investigational New Drug (IND) applications and amendments
- CTD templates preparation
- Marketing Authorisation Applications (MAA)
- New Drug Application (NDA)
- Responses to regulatory questions/Information Requests
- Variations/Post-Approval Changes