Nikita specializes in commercial law, contract law, and legal issues within the life sciences industry. He is an expert in the regulatory aspects of the circulation of medicines and medical devices, covering all stages from registration to disposal.
Moreover, Nikita is involved in compliance and sanctions law, including projects related to the unfreezing of investor assets, building compliance systems from scratch and maintaining them, conducting external compliance audits, and implementing policies and standards that reflect the company's industry specifics and anti-corruption legislation.
Nikita participates in legislative working groups updating the laws on human genetics in collaboration with key market players. In his work, Nikita also addresses issues of compliance regulation in scientific genetics and corporate self-assessment.
Selected Experience
Healthcare and Life Science
Nikita advised:
one of the world's largest pharmaceutical companies on the full range of legal matters in daily operational activities;
several pharmaceutical companies in developing and implementing commercial policies, including new strategic market approaches;
a Russian project to bring a COVID-19 vaccine to international markets — preparation of contract manufacturing agreements, technology transfer, transfer of regulatory powers and complex supply contracts, including contracts governed by English and Welsh law;
a Russian company — participant in one of the largest industrial groups — on localising medical device production under sanctions pressure;
clients in legislative and GR activities on innovative models of medical care delivery — preparation of regulations, concepts, negotiation support;
clients in countering grey importers of medicinal products;
one of Russia's largest medical device manufacturers on a wide range of regulatory matters.
Sanctions Law and Compliance
Nikita advised:
private clients on unblocking frozen assets in Euroclear and Clearstream systems;
companies in developing and refining compliance systems, including new procedures and standards;
chemical industry and IT sector enterprises during external compliance audits;
clients on anti-corruption restrictions applicable to management of companies included in special lists and sanctions;
majorpharmaceutical companies in implementing compliance procedures and conducting compliance investigations.
achievements
Ratings and Awards
Nikita is endorsed by Russian ratings, including: Pravo-300, Rossiyskaya Gazeta.
Pravo-300 in the nominations: Compliance, Sanctions Law, Pharmaceuticals and Healthcare (Medicine and Healthcare), Pharmaceuticals and Healthcare (Pharmaceuticals), Retail, FMCG, Public Catering, Private Equity (High Market)
Rossiyskaya Gazeta in the nomination: Healthcare and Pharma