Regulations

Medicinal products

  • we select the appropriate registration strategy for our clients,
  • we carry out the subsequent stages of product development, including offering the manufacturing of tested medicinal products,
  • in accordance with current legal requirements and ICH guidelines, we provide support in the registration of medicinal products in Poland and the European Union,
  • we prepare complete registration documentation in CTD/eCTD format and offer to manage the medicinal product registration process on behalf of the client, either through national procedures or European procedures.
  • we conduct a dossier audit, which involves verifying the compliance and completeness of the registration documentation to ensure its continuous usability in registration processes.

Produkty lecznicze CHC foto

wyroby medyczne CHC foto

Medical devices

  • we evaluate the device in terms of composition, route of administration, dosage regimen and intended use,
  • we determine the correct classification of the medical device,
  • we provide the design and development of medical devices, including the preparation of technical documentation, which also covers the clinical evaluation of the device and risk analysis
  • we offer comprehensive assistance in the registration of a medical device in accordance with current requirements (EU Regulation 2017/745), including the involvement of a Notified Body,
  • we assist in the registration of manufacturers, importers, and medical devices in the EUDAMED database,
  • we provide services related to post-market surveillance (PMS, PMCF).

Dietary supplements

  • we offer the design of dietary supplements,
  • we prepare and analyse the composition and labelling,
  • we notify dietary supplements to the sanitary authorities
  • we provide support in obtaining the Free Sale Certificate (FSC)

suplementy diety CHC foto

Pomoc eksperta

W strukturach CHC posiadamy Eksperta z ponad 20-letnim doświadczeniem w zakresie farmakognozji, a zatem polecamy się również w zakresie opracowania opinii naukowych na temat surowców roślinnych stosowanych w produktach leczniczych, wyrobach medycznych czy suplementach diety.