medical writing

inSeption provides end-to-end solutions that span the full spectrum of writing services, QC, technical editing, and submission-level publishing.   We have been relied upon to deliver critical submission documents for global regulatory authorities for numerous clients throughout the years.  

inSeption offers a flexible and scalable business model that aligns with our clients unique situations, while always maintaining an unwavering focus on quality resources.  

Our concentration within this niche community has allowed us to develop many long-term relationships, by which we rely.   For the sponsor, it means the difference between the best writers ON the market, as compared to the best writers IN the market.

Overview of Services Provided:

  • NDAs, MAAs, INDs, BLAs…
  • Clinical Study Reports
    (phase 1, 2, 3, and 4) 
  • Clinical Protocols
  • Investigator Brochures & Updates
  • CTD Clinical Summaries & Overviews
  • Integrated Summaries of Safety
  • Integrated Summaries of Efficacy
  • Safety Narratives
  • Briefing Documents
  • Publications Writing
  • Product Labeling
  • Technical Editing
  • Content Review
  • Quality Control
  • Quality Assurance
  • Compilation of appendices
  • Creation and formatting of tables
  • Proofreading
  • Submission-Level Publishing
  • Templates and SOPs