Regulatory writing is the generation of specialized documents for submission to health authorities (HA). Most regulatory documents have guidelines that detail the requirements, but a comprehensive understanding of current HA expectations is necessary to do it well. AO Regulatory Consulting generates and copyedits the following documents:
- Health authority inquires and responses
- HA meeting requests and briefing packages
- Development Safety Update Report (DSUR)
- IND annual reports
- Expedited access requests
- Pediatric plans
- Orphan drug designation requests/annual reports
- Expanded access/compassionate use IND
- Clinical trial and investigational new drug (CTA/IND) applications
- Drug master files (DMF)