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What documentation is available for the CTD (Common Technical Document)?

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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 this issue, please contact us or your local representative.

Other questions - General regulatory

Do Roquette products comply with Pharmacopeias?

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Do Roquette’s liquid sorbitols comply with the USP/NF monograph?

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Is DMF documentation available for Roquette products?

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