Is analytical validation information for the assay of the API required to be submitted with the dossier? 1.64K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K September 29, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted September 29, 2020 0 Comments Spread the loveInformation on validation is required if an in-house method is used. Such information is not required if the assay method is pharmacopoeial. Spread the love Login
