Regulatory Affairs
We offer a wide range of services in the RA area.
Our Regulatory Affairs support covers various pharmaceutical forms of medicinal products, medical devices, food supplements, cosmetics and veterinary products.
We also provide support with the research and development (R&D) activities, including RA service, for the products manufactured at CHC, i.e. softgel capsules and liquids, from a concept to a finished product.
For our Clients we offer: accurate identification of their needs and requirements based on reliable consultancy in the R&D field supported by knowledge and experience, preparation of expert reports, development of documentation, as well as comprehensive, professional analytical services in modern laboratories
Our services in the RA area include, in particular:
- preparation of documentation for OTC switch (medicinal products)
- pharmaceutical consulting,
- audit of active substance or drug product documentation (dossier audit),
- preparation of expert reports (clinical, non-clinical, ecotoxicity, PDE value as well as quality overviews),
- preparation and modification of the product information (SmPC, Leaflet, Instruction for Use, Labelling) and Leaflet readability testing,
- carrying out activities concerning medical devices (assessment of medical devices in terms of compliance with current EU requirements – MDR, update of technical file, provision of surveillance-related services after the marketing of medical devices (PMS, PSUR and PMCF).
We are also proud to have an expert in pharmacognosy with over 20 years experience in our team, who prepares reliable scientific opinions and reports concerning plant raw materials used in medicinal products, medical devices and food supplements.
