Expert 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.

  • Addendum Reports
  • Biowaiver Justification
  • Clinical trial protocol
  • Dossier Writing
  • Dossier Technical Review
  • Environmental Risk Assessment Justification/Waiver/Preparation
  • Justification report – Clinical / Non-Clinical
  • Module 2 document preparation/update
  • Module 2.3 preparation/update (CMC/Quality)
  • Module 2.4 preparation/update (Pre-Clinical Overview)
  • Module 2.5 preparation/update (Clinical Overview)
  • Module 2.6 preparation/update (Pre-Clinical Written and Tabulated Summaries)
  • Module 2.7 preparation/update (Clinical summary)
  • Module 3 document preparation/update
  • Module 4 document update
  • Module 5 document update
  • PSUR Writing/update
  • Risk Management Plan Creation/update
  • SPL Writing
  • Strategy Report
  • Literature Search Report