Regulatory affairs
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, European Union and US.
Bertin Pharma offers a comprehensive range of services in the field of regulatory affairs:
- 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 (see also service information sheets), and in relation with well-recognized experts, the technical data is organized in the requested French or English format:
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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
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Set up of finished product specifications and internal monographs
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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
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Marketing Authorisation dossier writing-up
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IMPD (Quality part)
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CTD Module 3
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Module 2.3 in connection with well-recognized experts
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Submission follow-up and regulatory support for questions from the agencies
- Stand-alone services
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Evaluation of pharmaceutical documentation (DMF, CTD)
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Determination of technical and document prerequisites
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Marketing Authorisation dossier follow-up in compliance with European standards
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Reformatting into CTD structure
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Dossier audit and updating
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Type I and II modifications
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Management of analytical or formulation studies when and if required
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Our related services
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Preformulation & formulation
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Industrial transfer
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Manufacturing & packaging
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Quality control & dispatch of clinical supplies
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Analytical development & stability studies
