Crid Pharma Clipa - Logo Contract Health Products Development Organization

Logo Amatsi

Pharmaceutical Writing IMPD

   
 
 

Our Regulatory Affairs department has extensive experience writing and submitting marketing authorization dossiers through French and European Regulatory Authorities.

IMPD - Pharmaceutical writing

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.


ICH Stability Studies   Investigational Medicinal Products
 
 

Home |  CRID PHARMA |  Analytical Development and Formulation Development |  ICH Stability Studies

IMPD - Pharmaceutical Writing |  Investigational Medicinal Products |  Importation, Control and QP Release Rervices

Manufacturing of Clinical Supplies and Packaging of Clinical Supplies |  Storage and Distribution |  Sterile Manufacturing Facility

Map | Contact |  Links | Legal Mentions

CRID PHARMA / CLIPA all rights reserved.