Regulatory Affairs 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

The regulatory affairs department will be preparing the pharmaceutical documentation working in parallel of the development activities in order to deliver the dossier as soon as all the technical data will be available either as full development package or stand alone services.

Full Development Package

In connection with the Formulation and Analytical Departments, and in relation with well-recognized experts, the technical data is organized in the requested French or English format:

• 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
• set 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
• marketing authorisation dossier writing-up
• IMPD (Quality part)
• CTD Module 3
• module 2.3 in connection with well-recognized experts
• submission follow-up and regulatory support for questions from the agencies

Stand-Alone Services

• evaluation of pharmaceutical documentation (DMF, CTD)
• determination of technical and document prerequisites
• marketing Authorisation dossier follow-up in compliance with European standards
• reformatting into CTD structure
• dossier audit and updating
• type I and II modificationspasting
• management of analytical or formulation studies when and if required