Pharmaceuticals & Life sciences

The BGP Litigation Pharmaceuticals and Life Sciences Practice is a huge team that renders services to 80% of pharma companies on the Russian market. The Practice provides comprehensive legal support for projects of major domestic and foreign producers of medicines and medical items, as well as companies in other business sectors fulfilling tasks associated with medicine, healthcare and digitisation of the sector. Our work involves advice on legal aspects of organising healthcare and on life sciences law, support for company R&D and clinical trials, production, registration and promotion of medicines and medical items, commercial activities in the pharma sphere and medical item circulation, IP, compliance, digital health projects, etc.

The Practice’s lawyers are experienced in providing turn-key support to pharmaceutical companies, virtually acting as the client’s full legal department and handling all legal issues that arise.

The BGP Litigation team of lawyers possess a profound understanding of the sector’s specifics thanks to active interaction with regulatory bodies, including the Ministry of Health, Roszdravnadzor, Rospotrebnadzor, the Federal Antimonopoly Service and others. They also have knowledge of the regulatory requirements on circulation of medicines and medical items at all stages of their life cycle.

We have unique experience of developing and introducing experimental legal frameworks in the Russian Federation designed for developing the sector. Another distinguishing aspect of our work is promotion of the GR agenda of companies working in the fields of medicine and healthcare. We support businesses in implementing innovative projects, including as part of federal import substitution projects in pharma and healthcare, and advise clients in the sector on operating under sanctions.

As a multi-service team of lawyers, we offer effective solutions to M&A issues and financing of company assets in the fields of medicine and healthcare, licensing, intellectual property, data security, protection of competition, labour relations, compliance and so on. We have experience of working in over 80 jurisdictions and assist in implementing large-scale projects of global and Russian companies.

Experience
Creating a strategy for a pharmaceutical company for promoting its drug portfolio
Our team has provided comprehensive legal support of a project for the promotion of drugs in the territory of Russia and the CIS, including working out risk matrices for each of the selected countries and the ways to mitigate such risks for each of the drug promotion devices. The pharmaceutical portfolio included over 30 SKU.
Medical 3D printing
Our team is advising a client on a project for the sale, in the territory of the Russian Federation, of dental 3D printers and related software registered as a medical product. Being one of the authors in the area of legal regulation of medical software, our Life Sciences & Technology practice’s team is providing comprehensive qualified legal assistance in developing the business model for the sale of the product, including active consulting on regulatory issues and drafting the necessary agreements.
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