CMC Filings

Medicilon provides CMC filing services. Usually, the research content of CMC preparations is arranged in a CTD format based on the ICH M4 module. Materials in the CTD format are compliant with ICH members, such as the NMPA and FDA. Translation into different languages can be provided according to clients’ requirements.

Download

The following is a composition of CTD materials used in preparation technology:
3.2.P Preparation3.2.P.1 Form and product composition 3.2.P.2 Product development3.2.P.2.1 Formulation3.2.P.2.1.1 API 3.2.P.2.1.2 Ingredients3.2.P.2.2 Preparation3.2.P.2.2.1 Formulation development process 3.2.P.2.2.2 Excessive dosage3.2.P.2.2.3 Relevant preparation characteristics 3.2.P.2.3 Production process development3.2.P.2.4 Packaging systems3.2.P.2.5 Microbial properties 3.2.P.2.6 Compatibility 3.2.P.3 Production 3.2.P.3.1 Manufacturer 3.2.P.3.2 Formulation batch3.2.P.3.3 Production process and process controls 3.2.P.3.4 Control of key steps and intermediates3.2.P.3.5 Process verification and/or evaluation3.2.P.4 Ingredient control3.2.P.4.1 Quality standards 3.2.P.4.2 Analytical methods 3.2.P.4.3 Verification of analytical methods3.2.P.4.4 Basis for quality standards 3.2.P.4.5 Human- or animal-derived ingredients 3.2.P.4.6 New ingredients 3.2.P.5 Preparation quality control 3.2.P.5.1 Quality standards 3.2.P.5.2 Analytical methods 3.2.P.5.3 Verification of analytical methods 3.2.P.5.4 Batch analysis 3.2.P.5.5 Impurity analysis 3.2.P.5.6 Basis for quality standards 3.2.P.6 Reference substances 3.2.P.7 Packaging systems 3.2.P.8 Stability 3.2.P.8.1 Stability conclusions 3.2.P.8.2 Post-approval stability study plan and commitment 3.2.P.8.3 Stability data
During preparation R&D, we will examine carefully and comply with the laws and regulations of the country or region where the application is filed—including such details as the registration number/DMF number or overall ChP/USP ingredient and packaging requirements—as well as the differences in pharmacopoeias of different countries on microbial limits during verification of analytical methods, so as to ensure that customers can successfully complete the clinical application of new drugs.
Our strength of CMC filing lies in
Our specialized application team, who possess an excellent track record after many successful applications in China and other countries around the world .The documents can be provided based on CTD templates or forms required by clients to meet local requirements.Our CMC filing can be integrated to include preclinical toxicology, clinical research, and drug administration services to provide a comprehensive package.

Relevant laboratories