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Case Studies

CEP dossier

Creation of a full CEP submission was requested by one client. This was to move from internally managed Module 3.2.S documents to a stand alone set of documents that would firstly be submitted to the EDQM for assessment/approval and then enable the client to commercialise its active substance more comprehensively to global clients.

The Solution

The client needed a CMC expert with solid experience in building complete Module 3.2.S CMC sections from multiple sources. Regulink supplied a CMC expert in less than one week to support this project, which ran for approximately 6 months end-to-end.

The budget for the project was under £50k and Regulink actually came slight under budget due to the excellent skills of the CMC expert and their ability to work rapidly, under pressure to create high quality CMC documentation.

The Outcome

The CEP submission itself is still in ongoing assessment. There have been some RFIs as expected, which have mostly centred around the manufacturing data. The questions were expected based on the type of product and fall in line with the standard review process at the EDQM. The overall timelines for the project have drifted slightly since the end of Regulink involvement due to challenges within the EDQM itself (partly linked to COVID).

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