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)
We support you throughout all steps of the conception and lifecycle of your products ensuring a complete quality service.
Thanks to our participation to international networks Regulanet and Pharmaxi, we have a privileged access to specialists in more than 90 countries.
STRATÉGIE SANTÉ
53, Boulevard de la Reine
78000 Versailles - France
Tél : +33 (0)1 42 86 86 00
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