Medical Writing

10

Of successful experience

Medical Writing Services

Vigipharma provides comprehensive scientific medial writing solutions to suit your medical and pharmaceutical documentation needs. These include regulatory submissions, non-clinical and clinical documentation. Our services include and are not limited to:

01: REGULATORY & CLINICAL WRITING
  1. Preparation of Clinical Study documents such as Protocols and amendments to protocols, Informed Consent Forms (ICF), Clinical study Reports, (CSRs), Investigator Brochure (IB).
  2. Preparation of Marketing Authorization Applications including non-clinical and clinical sections of the Common Technical Document (CTD), summaries and overviews.
  3. Standard Operating Procedures (SOPs)
  4. Pharmacovigilance documents such as PSURs/PBEREs, DSURs, RMPs
  5. Dear Doctor & HCP Letters
  6. Patient information materials such as Patient Information Leaflets
  7. Drafting responses to Regulatory authority
  8. Developing Pharmacoepidemiological study reports
02: SCIENTIFIC WRITING

Abstracts, Manuscripts, journal articles, posters and presentations