Regulatory affairs and patent law

Registration medical products (medicines, medical devices, food supplements)
  • Assessment of the possibility of registration medical products in export country
  • Gap analysis of dossier and technical documentation
  • Analysis of technical documentation of API and raw materials suppliers
  • Consultations on adaptation of the instructions for use and packaging design for export markets
  • Assistance in dossier forming in accordance with the requirements MOH of export country
  • 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 bringing the 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 export market
  • Patent search by name and recommendations for choosing a trademark
  • Recommendation in naming and supporting in choosing name in accordance to linguistic specifics of each country
  • Applying for registration trademark
  • Processing requests, preparing a response to the request

The DuoPharm team has many years of experience in the field of registration of medical products on international markets and offers you services to support regulatory processes at all stages — from gap analysis and preparing dossiers to conducting the re-registration procedure.

We know about all the “pitfalls” of the complex process of getting market authorization (registration) in export countries, and how to get around them. You will get information about the terms of registration, upcoming expenses and, most importantly, whether to start the process of registering a product in a new country before all work begins.

One of the most point in process of expanding your business globally is to care about saving your investments. Register trademark of your company and your products is highly necessary to avoid to obstacle in future. The Duopharm team will help you to understand all points of the process and will support you all the stages: from patent search and to registration your trademark.

Any questions left?

Call +7 812 967 88 87 or leave your enquiry in the form below
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