Dossier audit
The evaluation of registration documents for completeness and the possibility of using them repeatedly is a very important process, particularly for the continuity of operation of a pharmaceutical company. Regular audits of product documents (by an external unit, KMJ pharma® Sp. z o.o.) allow the company to maintain high quality standards and safety of operation by an early detection of non-compliance in the documentation that may affect patient safety and a financial situation of the company (product recalls, suspension of marketing).
We carry out audits of files in accordance with the highest standards and attention to detail. We put special emphasis on highest risk areas. During an audit, we verify e.g. the correctness and promptness of documentation updates, its (technical) correctness, its completeness vs. applicable requirements and compliance with the documentation approved (e.g. by post-registration changes).
When ordering an audit service for files (whether registered or before registration), you receive a detailed post-audit report, in which we will present information about any gaps or errors in the documentation, along with a suggestion about the method for correcting or filling them.
Due diligence
The “Regulatory Due Diligence” audit is carried out at the request of a client in order to make an in-depth analysis of a specific entity responsible, which is a potential subject of acquisition, regarding its legal situation, in particular with regard to its portfolio of marketed products. Our task is to identify risks in the documentation of products and to evaluate the potential and compliance of the documentation (before entering into actual negotiations regarding capital transactions).
This audit is carried out in such areas as:
- files of medicinal products, medical devices, cosmetic products,
- production of medicinal products, medical devices and cosmetic products (if there are no valid GMP certificates).
The Regulatory Due Diligence audit is a completely individualized procedure, every single time adjusted to the specificity of the examined entity and the type of its products.
One of the basic conditions of carrying out a RDD correctly is an appropriate selection of experts. The RDD requires an interdisciplinary team consisting of experts in nonclinical/clinical quality documentation. Our long-standing experience in preparing product documentation gives us a broad, integrated and prognostic approach to the evaluation of documents, whereas the knowledge of current legal requirements allows us to evaluate the level of documentation compliance.