We offer a full range of services regarding the registration of medicinal products, medical devices and biocidal products:

• conducting and monitoring the registration process of medicinal products to the market in the national procedure and MRP/DCP
• local support for the registration in the Central procedure
• audit, development and verification of registration documentation
• conducting the process of post-registration variations, re-registration and notification
• carrying out the “sunset clause exemption” procedure
• preparation of the texts of the Summary of Product Characteristics (SmPC), information leaflets and packaging
• preparation of the expert reports
• preparation and verification of the educational materials
• preparation and verification of the graphic designs
• tests of the readability of the patient information leaflet
• coordination of analytical tests of medicinal products, including tests after the first placing on the market
• representation of Marketing Authorisation Holders (MAHs) in dealings with Polish administrative authorities: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Ministry of Health, Pharmaceutical Inspectorate, Sanitary Inspectorate and others
• consulting concerning pharmaceutical law and local requirements
• expert translation services: medicine and pharmacy
• preparation of the required documentation and coordination of the reimbursement process for medicinal products, reimbursement negotiations
• clinical trials of medicinal products
• pharmacovigilance
• preparation of documentation and notifications regarding medical devices and biocides

   

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• preparation of documentation and notification of dietary supplements
• preparation of documentation and notification of cosmetics.
  

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