The Regulatory Affairs department plays a key role in ensuring that your future or existing product will comply with the permanently updated guidelines and recommendations of the regulatory bodies in France, EU and US.

A comprehensive range of services:

* Regulatory approach Strategy * Dossier audits & recommendations * CTD module 3 writing up * IMPD writing up * CE Labelling documentation * Submission follow-up and regulatory support for questions / comments from Agencies

* Specifications, in-house monographs and compilation of scientific data
related to the raw materials, active substances, impurities, primary
packaging to perform the writing up of Drug Substance (S) Part
* Setting up of finished product specifications and internal monographs
* Compilation of all the documents related to pharmaceutical development, the
analytical validation and the manufacturing of pilot batches and process
validation to perform the writing up of Drug Product (P) Part
* Writing up and finalization of Module 3 and of IMPD* Sum up of Module 2.3 in connection with well-recognized experts

* Evaluation of pharmaceutical documentation (DMF, NTA, CTD)
* Determination of technical and document prerequisites (Pharmaceutical product, OTC, Medical device)
* Modifications of existing dossiers up to European standards
* Setting up of minor or major variations related documentation
* Management of analytical or formulation studies when and if required
* CE certification strategy, writing up of technical and conception dossiers