Medical Writing is a vital piece of the pharmaceutical business as it requires particular information and abilities to introduce the ideal logical data in a very much organized way.
At NAVATIOPHARMA, we have a group of specialists who other than having fantastic composing abilities can grasp the specialized language and tailor it to suit the prerequisites of the essential record.
REGULATORY WRITING
- Investigational New Drug Applications (INDs)
- New Drug Applications (NDAs)/Biologic Licensing Applications (BLAs)
- 505(b)1 and 505(b)2 NDAs
- Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
- Annual safety reports, including Development Safety Update Reports (DSURs)
- Briefing books for pre-IND/EOP2/pre-NDA
- Regulatory responses
- Prescribing information
- Orphan drug requests
- Fast track designation requests
- Qualified infectious disease product requests (QIDP)
CLINICAL WRITING
- Clinical Trial Protocols (Phase I to III)
- Clinical Study Reports (Phase I to III)
- Investigator Brochures
- Patient narratives
SCIENTIFIC WRITING
- Abstracts
- Posters
- Manuscripts
- Literature-based research
- White papers