We perform dossier audits for medicinal products or active substances (Active Substance Master File), which include verification of its contents with the current EU requirements and the ICH guidelines.
We perform dossier audits (CTD, NeeS format) with attention to the smallest details, using appropriate standards implemented within the company.
We take great care to ensure that the content of dossiers complies with international, European and national guidelines on the quality data as well as pre-clinical and clinical data of original, generic and well-established medicinal products (WEU — Well Established Use).
When performing audits, we assess, in particular, the correctness, accuracy and timeliness of updates to the registration documentation, the completeness thereof in both substantive and legal terms, and the compatibility of the submitted dossier with the documentation approved (e.g. in another country or modified as a result of post-registration variations).
Having performed a dossier audit (of registered, modified or pre-registered products), we provide our customers with detailed post-audit reports which include information on deficiencies, inconsistencies or errors in the dossier together with recommendations on how to remove or supplement them.
Wysogotowo ul. Batorowska 52 62-081 Przeźmierowo POLAND District Court for Poznań - Nowe Miasto and Wilda in Poznań, the 8th Commercial Division of the National Court KRS 0000871229 NIP 781-00-41-371 Share capital: 36 100 000PLN