We support client’s technical writing needs including preparation of:
- 1. CMC and clinical sections of INDs, NDAs, DMFs, PASs, and CBEs
- 2. IND and NDA annual reports
- 3. Briefing packages for:
- Pre-IND meetings
- End-of-Phase II meeting
- Pre-NDA and Pre-NDA CMC meetings
- Meetings to address Complete Responses from the FDA and other global HAs