Medical Writing

Medical writing is a specialized form of technical writing that involves creating documents related to medicine, healthcare, and related fields.

Medical Writing Services Overview

Scientific Writing

Manuscripts
Abstracts
Posters
Create, update and maintain database for Standard Responses (FAQs)
Research and Review articles
PPT Presentations and Conference grids
Conference support
KOL Support

Clinical Writing

IBs, Study Protocols for CT and BE studies
CSRs (Full, Synopsis, Web Synopsis)
Subject Narratives
Integrated Summary of Efficacy (ISE) and Integrated Summary of Safety (ISS)
INDs ARs/DSURs
IBs, Study Protocols for CT and BE studies

Reg & Post Marketing

Variations/amendments, Renewals and Annual updates
Manufacturing summaries
Process validation reports
Author/update labeling documents (CCDS, SmPC, USPIs, PILs) per PLR and QRD Template and other applicable guidelines
Author/update periodic reports (PSURs, DSURs, PADERs, PBRERs, CARs)
Safety Updates, Risk Management Plan (RiskMaps, EURMP) and Risk Benefit assessments
Summary Bridging Reports and Ad-hoc reports

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