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