Medical Writing and QC

inSeption provides medical writing services as well as strategic submission planning expertise to ensure that your application is of the highest quality. Our highly experienced, fully dedicated team integrates with your organization to credibly manage the complexities of timeline creation and management, resourcing, document interdependencies, and transmission through the Electronic Submission Gateway (ESG).

Medical Writing

Global regulatory submissions, Modules 2-5 of the eCTD
CSRs (Phase 1-4)
Orphan Drug Applications
Investigator’s Brochures
Clinical Protocols and Amendments
Safety Narratives
Annual Reports
Briefing Books
Responses to agency questions
Pediatric Study Plans and Pediatric Investigation Plans
Publications (abstracts, posters, manuscripts)
Public disclosure writing

Quality Control

100% QC of all documents
Verification of consistency across all documents

Regulatory Operations and Submissions

Document-level formatting and publishing
Publishing and maintenance of eCTD submissions
Transmission to health authorities (ESG)
Strategic consulting and process optimization

Overview of Expertise

inSeption’s Global Regulatory Documentation Group provides seamless collaboration on documents and submissions throughout a spectrum of services: medical writing, quality control review, document- and submission-level publishing, and health authority submission management. We have the flexibility to manage all aspects of
your regulatory writing program, either as a fully-dedicated partner or as individual contributors to fit within your existing team.