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
- preparation of documentation and notifications regarding medical devices and biocides
- preparation of documentation and notification of dietary supplements
- preparation of documentation and notification of cosmetics.
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