Regulatory affairs and patent law

Registration medical products (medicines, medical devices, food supplements)
  • Gap analysis of dossier and technical documentation
  • Analysis of technical documentation of API and raw materials suppliers
  • Consultation on adaptation of the instructions for use and packaging design to requirements of local MOH
  • Assistance in dossier forming in accordance with the requirements Russian MOH and the EAEU regulations
  • Applying for registration medical products
  • Processing requests from MOH, preparing a response to the request
  • Re-registration of medical products
Patent search and trademark registration
  • Search for patentability
  • Assessment of the patent and legal possibility of access product to the market
  • Recommendations for developing (or changing) the composition of drugs to access product to new market in case if similar composition of drugs is under patent protection in the market
  • Patent search by name and recommendations for choosing a trademark
  • Applying for registration trademark
  • Processing requests, preparing a response to the request

The pharmaceutical and medical industry is one of the most strictly regulated area of production and business. Long period of market authorization (registration) processes, government control of selling medical and pharmaceutical products make the tasks in regulatory area one of the most complex and require a comprehensive approach to their solution.

DuoPharm specialists have many years of experience in regulatory affairs. The professional team of DuoPharm is ready to offer you an assessment of the completeness of dossiers and technical files, assistance in forming a technical documents in accordance with requirements, supporting the registration and re-registration procedure, and many other services in the field of medical products registration.

It is important to pay special attention to patent law and trademark registration. The strength of your company depends on the market strength of your brand. To avoid losing of your brand and your money, extremely necessary to register your trademark and get all patents from A to Z and protect your intellectual property. The DuoPharm team of patent attorneys has many years of experience in the field of patent law in the pharmaceutical industry and will provide you with all types of services from consulting to obtaining a patent.

Any questions left?

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