What documentation is available for the CTD (Common Technical Document)?
Roquette can provide all the information requested in the standard Common Technical Document (CTD). However, in order to simplify the customer’s NDA files, Roquette has not only submitted several DMFs to the US authorities but also several CEPs (Certificate of Suitability to the monograph) to the European Medicinal Authorities (EDQM). Roquette DMF and/or CEP Access Letters are therefore available to the NDA applicant upon request. Moreover, in connection with the New Pharmaceutical Affairs Law (New PAL), implementation, Roquette is preparing new DMF submissions to the Japanese authorities. For more information on the DMF status of a particular product, please contact us or your local Roquette representative.
Related Questions
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- How much detail is needed in a business or technical document?
