Life sciences

Full-fledged restructuring of a business of a large European pharmaceutical company Lawyers of the practice provided legal support during a project that involved the restructuring of the business of a European pharmaceutical company (group of companies) in Russia.

Conducted a regulatory risk-based audit for a Chinese pharmaceutical company For a Chinese pharmaceutical company, lawyers of the practice conducted an audit of regulatory risks associated with products that were imported into Russia.

Successfully defended the client in court: the lawsuit was declared unfounded and was dismissed Lawyers of the Life Sciences Practice represented a major international pharmaceutical company which devised a methodology for measuring certain substances in waste water. 

Templates of agreements for the provision of professional services in the field of health and science

Tax support for the export of medicines The lawyers of Pepeliaev Group's tax department have supported transactions aimed at exporting medicines into foreign markets.

Dispute concerning VAT being collected on the cost of work aimed at organising clinical studies Pepeliaev Group’s lawyers have represented a pharmaceutical company in a dispute with the tax authority in relation to VAT being collected on the cost of the work aimed at organising clinical studies. We won the dispute in the first instance court.

Tax audits Pepeliaev Group’s lawyers have summarised court practice relating to the tax classification of contracts for the organisation of the study of medicines, developed arguments in case the tax authority would raise claims and supported the client in gathering evidence (prepared the defence files) ensuring the defence of the client's interests during a tax audit.

Hospitality expenses on healthcare professionals The lawyers of Pepeliaev Group’s tax department have devised documents minimising tax risks when paying expenses on healthcare professionals.

Advising on tax and regulatory issues Pepeliaev Group’s lawyers have provided advice on tax and regulatory issues concerning a manufacturer of medical products interacting with healthcare professionals.

Closure of a representative office Pepeliaev Group’s lawyers have handled the closure of a representative office which pursued auxiliary and preparatory activities in Russia, and successfully protected the company's interests at the stage of the pre-audit analysis by the tax authority.

Contractual model for foreign software to be sold in Russia Pepeliaev Group’s lawyers have devised a contractual model for foreign software to be sold in Russia (including for payments to be accepted for updates and additional features of the software), taking into account the tax risks. 

Manufacturing and selling a medicine within a group of affiliated companies Pepeliaev Group’s experts have consulted a client in relation to the tax implications and risks pertaining to a contract for the manufacturing and selling a medicine within a group of affiliated companies, taking into account the actual distribution of functions and pharmaceutical licences. 

Formalising contractual relationships with sales outlets concerning the marketing of products Pepeliaev Group’s lawyers have developed several options of formalising contractual relationships with sales outlets aimed at marketing the company’s products if there are no supplier-recipient relationships for such products. 

Contractual manufacturing of active pharmaceutical ingredients and biological substances Pepeliaev Group’s lawyers have provided legal support to a client within the framework of organising the contractual manufacturing of active pharmaceutical ingredients and biological substances jointly with a Russian pharmaceutical company. 

Investing in production and acquisition of new assets Pepeliaev Group’s services also encompass legal support for Russian and global companies in relation to the legal aspects of business development, namely, investing in production and acquisition of new assets 

Changes in the distribution model in Russia Pepeliaev Group’s lawyers have advised a major international manufacturer of homoeopathic medicines on issues relating to a change in the distribution model in Russia 

Antitrust audits The experts of our antitrust practice have conducted a lot of antitrust audits in relation to the activities of pharmaceutical companies, accumulating thus a wealth of knowledge concerning the specifics of this industry’s business in the Russian market.

Biotech startups For several years, Pepeliaev Group’s experts have successfully supported the activities of two biotech startups created by foreign investors together with one of the Russian development institutes. 

Full-fledged legal support for a pharmaceutical company Pepeliaev Group’s lawyers have advised one of the 10 world’s largest pharmaceutical companies on a broad spectrum of issues concerning its current activities

Clinical trials in Russia Pepeliaev Group’s lawyers provided support to one of the world’s largest pharmaceutical companies performing clinical trials in Russia