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