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.