Selection of Global Regulatory Services:
- Product development strategy
- Health Authority interactions
- GAP analysis in case of market expansions
- Authoring / writting and QC of all global regulatory documentation
- Marketing authoritsation application procedure (EU and ROW)
- NDA/BLA FDA
- Regulatory complience
- All product launch activities
- Post-approval changes
- Renewals
Selection of Global CMC services
- Technology Transfer
- Manufacturing POC and commercial process
- Process validation / PPQ
- Method development and validation
- DS and DP formulation development
- IP scan
- Labelling and supply for clinical studies
- Vendor selection and management
Specialist Services
- Due Diligence support
- Geographic expansion
- Initiate offices in EU, Asia and US
- GAP analysis
- Strategic and tactical support
- Dossier authoring
- Support Out - License process
- Finding Out - License partners