NON CLINICAL AND CLINICAL
- Scientific and medical writing: Non clinical and clinical sections of the eCTD dossier
- Development of the Pediatric Investigation Plan (PIP) and of the pediatric clinical protocols
- Design and implementation of non-clinical and clinical parts of the dossiers
- Clinical development plans and protocols
- CTD format Summaries and Overviews
- Risk Management Plans (RMP)
- Periodic benefit risk evaluation reports (PBRER)
- Notes of therapeutic interest (French Commission of Transparency)
- Scientific communication tools (abstracts, posters, manuscripts, slide sets)
