Background

Medical and pharmaceutical writing

SYNAVIA boasts expertise and network of writers skilled at creating meaningful texts. We carefully evaluate the purpose and the context of each writing; documents completed by us are well structured and concise. We focus on medical and scientific accuracy as well as on professional interpretation of the available evidence.

We offer the writing of many different documents, including: 

  • Clinical and Non-clinical Overviews (CTD Modules 2.4 and 2.5)
  • BCS-based biowaivers
  • Variation reports
  • Quality Overall Summary (CTD Module 2.3)
  • Investigational Medicinal Product Dossier (IMPD)
  • Module 1.5.1 and 1.5.2 for Bibliographical and Hybrid Applications
  • Justifications, expert reports, deficiency letters, impurities assessment, biowaivers, etc.