is a small, private, independent consultancy provides professional services in the Regulatory Affairs area.
We assist foreign and local companies in obtaining the proper registration status of their products in Poland.
Due to the dynamic increase of the interest in regulatory affairs activities, we are looking for foreign and Polish partners interested in co-operating with us in this business.
„PharmConsult” offers its services related to the registration of medicinal products (Rx, OTC and plant origin), medical devices, food supplements and cosmetics.
We offer a complete range of activities:
– piloting and conducting the full registration process of medicinal products in the Polish Drug Registration Agency (Office for Registration of Medicinal Products, Medical Devices and Biocides); obtaining the Marketing Authorization (MA) – via MRP, DCP and national procedures;
– submission and monitoring the post-registration variation process;
– prolongation of Marketing Authorisation (renewal process);
– submission of application for parallel import;
– harmonisation of the dossier to the European law (update process);
– preparation, translation and adjustment of the texts of Patient Information Leaflets (PIL), Summary of Product Characteristics (SmPC), outer and immediate packaging (mock-ups) to the requirements of the Polish Drug Agency according to national and European law;
– application of medical devices to the Register of Medical Devices;
– notification of food supplements and cosmetics in appropriate Polish Agencies.
Our extensive experience allows us to advise on the most effective submission procedures that guaranty successful approvals/decisions ASAP.
We assure full confidentiality and customer data protection.
ul. Nadrzeczna 3
Phone/fax: + 48 22 780 40 30
Mobile: + 48 608 096 772