Dossier audit

Expert assistance
Within the CHC structures, we have an Expert with over 20 years of experience in pharmacognosy; therefore, we also offer our services in developing scientific opinions on plant materials used in medicinal products, medical devices, and dietary supplements.

Dossier audit
We provide services related to the audit of the medicinal product or active substance dossier (Active Substance Master File) for compliance with current legal requirements in the European Union and ICH guidelines.

We conduct dossier audits (CTD, NeeS format) with attention to the smallest details, applying the appropriate standards implemented within the company. We pay very close attention to the compliance of the contents of the dossier with international, European and national guidelines regarding quality data and pre-clinical and clinical information of original, generic and Well Established Use (WEU) medicinal products.

During the audit, we assess, among other things, the correctness, accuracy, and timeliness of registration documentation updates, completeness from a substantive and legal perspective, as well as the compliance of the submitted dossier with the approved documentation (e.g. in another country or modified as a result of post-registration changes). When carrying out the dossier audit service (for a registered product, modified product, or pre-registration), you will receive a detailed post-audit report, in which we will provide information on any deficiencies, inconsistencies, or errors in the documentation, along with recommendations on how to address or supplement them.