Medical Writing

We provide a comprehensive writing service for regulatory submissions, scientific communications and medico-marketing materials for a diversity of therapeutic areas, and for all phases of the product life cycle - from pre-clinical development to post-marketing literature. Ensuring you gain accurate, consistent and regulatory-compliant documents in a cost-effective, timely and flexible manner.

  • Clinical Trials Documents
    • Protocols
    • Investigative brochure / Product Manual 
    • Clinical study report (CSR)
    • Investigational Medical Product Dossier (IMPD)
    • Informed Consent Form
    • Case Record Form
    • Patient Diary
  • Product Monographs
  • CTD Documents
  • Module 2.4 - 2.7 preparation 
  • Module 4 & 5 review
  • SPCs and PILs, Pack Inserts, Product Information
  • Gap Analysis of medical writing
  • Environmental Risk Assessment (ERA)
  • Abstract and Manuscripts
    • Posters, Presentations and Promotional tools
    • Scientific justifications, Biowaivers, Medical rationales
    • Safety narratives