Services of CEP
CEP, also known as COS, that is the certificate of suitability to monograph of European pharmacopeia (COS/CEP), which is a way for APIs to quickly enter the European market.
CEP is only applicable to substances already recorded in EP, including chemical APIs, sterile APIs, herbs, etc.
The CEP application is reviewed by DCEP, a subsidiary of EDQM, and a CEP certificate will be awarded after approval.
If the API used in the proposed listed drug has obtained a CEP certificate, the certificate can be used directly in the marketing authorization application (MAA)\, and the quality of the API will no longer be evaluated.
The CEP certificate has been officially recognized by HC, TGA, and other authorities, which is of great significance for the rapid entry of APIs into the European high-end pharmaceutical market.
Our services include but are not limited to:
Technical review of the existing research materials of the applicant and guidance for supplementation;
Production of application documents and professional translation services;
Conversion and submission of application dossiers in eCTD format;
Interpretation of defect letters and guidance on defect closure;
Good communication with EDQM experts until CEP is obtained
Re-registration and change maintenance of CEP
