The client was an India-based global drug manufacturer who was looking for Regulatory support in the submission of Certificate of Suitability to the EDQM. The project came with several challenges like a lack of understanding of the EDQM requirements for CEP submissions and stringent timelines. Freyr ensured that the compilation and submission of the CEP in the eCTD format was completed on time. The CEP dossier preparation and submission was accomplished in a compliant manner by Freyr. Our regional expertise offered the necessary guidance in conducting the gap-analysis and mitigating the risks. Freyr was able to support the client in their business requirements by following the perfect Regulatory pathway.
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