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Active Pharmaceutical Ingredients – DMF & CEP

The general move of the pharmaceutical industry to outsource the Active Pharmaceutical Ingredient (API) manufacture to suppliers in non-EU regions provides challenges that Regulink can assist with, from interpretation of the regulatory landscape, discussions with the Competent Authorities, including EDQM and the preparation of dossiers for submission in the relevant format.

Regulink has an in-depth understanding of the complex procedures associated with API registration in Europe through the ASMF/DMF or via the CEP (‘Certificate of Suitability’ to the Monograph of the European Pharmacopoeia) procedure.

For new applications for CEPs for chemical purity in particular, it is important to avoid the common deficiencies associated with discussion on impurities (mutagenic) and related substances (carried over from the starting materials, SM), description of the process, definition and justification of SMs, control of the SM and reagents and solvents, elemental impurities, information on the synthesis of the SMs and their manufacturers etc.

Regulink has hands on experience with navigating through the detailed guidance in order to meet EDQM expectations and is therefore expertly placed to assist its clients with making successful applications for CEPs, whether they be for chemical purity and microbiological quality, for herbal drugs, or for sterile active substances.

Case Studies

Regulink has been involved in the compilation of a dossier for a new European Certificate of Suitability for chemical purity for one of its clients, with the EDQM, as well as managing and overhauling its Type II DMFs for the US. You can find out more about these specific projects, both completed very successfully, on time and budget, in our case studies section.

See our case studies →

OTHER REGULATORY AFFAIRS SERVICES

Whether it be a special regulatory project, intelligence, strategy or support with the essential life cycle management aspects, Regulink provides solutions that have delivered successful and cost-effective outcomes time after time. We are proud of the range and quality of services that we can provide, evidenced by the long term working partnerships we have established with our varied client list.

Licence Maintenance & LCM

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Regulatory Dossier Conversion, Preparation and Submission

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Regulatory Strategy & Intelligence – Marketed Products

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Special Regulatory Services

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