Regulatory affairs

We offer you services for medicinal products registration in Poland in compliance with national and European procedures (MRP, DCP) as well as post-registration affairs such as variations, renewals and notifications.

Our team leaded by prof. Przemyslaw M. Mrozikiewicz will provide you with the following:

  • registration dossier and its scientific review as well as carry out the full registration process at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (such as an application, a summary of product characteristics, a patient information leaflets)
  • expert reports (chemical, pharmaceutical, pharmacological, toxicological and clinical documentation, post-registration variations etc.)
  • translation of information leaflets
  • transformation of the NTA documentation into CTD
  • documentation of authorised herbal medicinal products adapted to the new regulations introduced by the Pharmaceutical Act
  • an analysis of a possibility to notify a product as a dietary supplement.