Regulatory Writing
- Protocols and protocol amendments.
- Informed Consent Forms/Patient Information Leaflets.
- Clinical study reports.
- Investigator Brochures.
- Clinical sections of common technical documents (CTDs).
- Integrated summaries of safety/efficacy.
- Literature summaries.
- Clinical expert reports.
- INDs, NDAs, BLAs, CTAs (Module 2) summary documents.
- IND and NDA Annual reports.
- Safety Aggregate Reports (PSURs, PADERS, DSURs).
- Clinical trial registry synopses.