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
Prescribing information
Orphan drug requests
Regulatory responses
Fast track designation requests
Qualified infectious disease product requests (QIDP)
Clinical Writing
Clinical Trial Protocols (Phase I to III), ICFs, CRFs etc
Clinical Study Reports (Phase I to III)
Investigator Brochures
Clinical & Non-Clinical Overview
Patient narratives
Scientific Writing
Abstracts
Posters
Manuscripts
Literature-based research
White papers
