Medical Writing

Intrinsik’s experienced team of medical writers consistently deliver high-quality documents using a flexible operational approach to meet client-specific requirements.


  • Investigator’s Brochures
  • CTD Modules 2.5 and 2.7
  • Integrated Summaries of Efficacy (ISE) and Safety (ISS)
  • Clinical Study Reports (CSR) and Clinical Study Protocols
  • Product Labelling (Product Monograph, Prescribing Information, Package Insert, Summary of Product Characteristics, Target Product Profile)
  • Risk Management Plans
  • Annual Reports
  • Orphan Drug Designations and Rare Pediatric Disease Designations
  • Systematic Literature Reviews
  • Abstracts and manuscripts for publication

How Can We Help?

Our scientists have the expertise to address your complex
toxicological health and environmental issues, including product
development and business risks to avoid scientific and regulatory delays.

Contact Us