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Our Regulatory Affairs department has extensive experience writing and submitting marketing authorization dossiers through French and European Regulatory Authorities.
Pharmaceutical Writing IMPD, Investigational Medicinal Product Dossier
We can provide the following services:
- Marketing Authorization (CTD format)
- Variations type I and II
- Dossier: audit / update
- Dossier registration to AFSSAPS and follow-up
- IMPD (Investigational Medicinal Product Dossier) according to the Clinical Trial Directive (2001/20/EC).
Our specialists participate to professional working groups organized by international associations and organizations. They maintain the best level of knowledge and the latest information on current and future regulatory requirements in order to deliver to our customers the best possible advice and strategy.
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