The practice renders comprehensive legal support of projects related to regulatory requirements to the turnover of drugs and medical products at all stages of their life cycle. Our team focuses on the legal issues of organisation of healthcare and the life sciences law, tech MA, data protection and circulation, regulatory compliance, as well as liaising with regulatory authorities.

The practice’s clients include major international pharmaceutical companies, manufacturers of medical products, FMCG, and beauty companies.

Areas of focus:

Legal support of R&D
•   Constructing contract strategies in the development of drugs and medical products
•   Legal support of transfer of exclusive rights to formulations, including any types of licencing (in / out licensing)
•   Advising on pre-clinical studies, including regulatory issues and contractual relationships
•   Legal support of biotech venture funds and start-ups

Drug clinical studies and trials
•   Building models of contractual relationships between the parties in organising clinical research and trials
•   Drafting agreements with research contractors, healthcare providers and other participants of trials
•   Finding solutions for complex regulatory, ethical and legal issues of organising clinical research and trials, including the issues of informing patients, data protection, import/export of biomaterials
Registration of drugs and medical products
•   Legal support of constructing the registration strategy
•   Assistance in preparing documents
•   Consulting on interaction with regulatory authorities

Manufacturing of drugs and medical products
•   Advising on building, maintaining and complying with the quality management system in manufacturing drugs and medical products
•   Legal engineering of models of the manufacturing processes, identification of risks, optimisation solutions
•   Comprehensive support of technology transfer transactions
•   Drafting localization contracts of any degree of complexity and contract manufacturing agreements
•   Consulting on the legal forms of government support

Pharmaceutical and medical product circulation business
•   Drafting, review and finalising any types of business agreements
•   Assistance in selecting business models for manufacturing, distributing and selling drugs and medical products
•   Advising on building, maintaining and complying with the quality management system in distributing drugs and medical products, including industry-specific quality issues
•   Drafting commercial policies, counterparty selection policies, policies on relations with pharmacy networks, bonus policies and agreements
•   Legal support of interaction with distributors and pharmacy networks
•   Representing clients in liaising with regulatory authorities on issues of business operations
•   Consulting on the issues of state procurement of drugs and medical products
•   Consumer disputes, other issues of consumer law

Promotion of drugs and medical products
• Review of marketing activities for compliance with the requirements of the Russian laws, identification and mitigation of risks
• Drafting and finalizing agreements for the creation and/or distribution of marketing materials

IP in the sphere of pharmaceutics and medical products
•   Patent disputes
•   Licence agreements (drafting, review, etc.)
•   Legal support of anti-counterfeiting and combatting “grey market” supplies
•   Legal support of trademarks, advising on the legal issues of “private label” goods

Compliance in the sphere of pharmaceutics and medical products
•   Building internal compliance procedures in the company (grading systems, limitations on hospitality, etc.)
•   Organising the company’s interaction with healthcare and pharmaceutical professionals
•   Anti-corruption audit, drafting and reviewing anti-corruption policies and clauses in the agreements with counterparties, other internal compliance by-laws
•   Anti-corruption due diligence of counterparties subject to the industry’s specifics
•   Investigations of potential violations of the Russian laws, risk analysis under the FCPA and UKBA
•   Holding a wide range of training events for employees, including stress-testing and checking the efficiency of implementation of compliance measures
•   Outsourcing the company’s compliance work
•   Industry studies (pay rates for HCPs, etc.)

Legal regulation of the circulation of beauty products and dietary supplements
•   Technical regulation of the beauty industry and dietary supplements
•   Support of business (building and analysing commercialization models, distribution agreements, agreements with retail networks, etc.)
•   Promotion of beauty products and dietary supplements
•   Consumer law issues

GR – interaction, state control and supervision
•   Advising on the issues of control over the circulation of drugs and medical products
•   Representation and defence in the relations with the FAS of Russia, the Federal Service for Surveillance in Healthcare, the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, and other regulatory and supervisory authorities
•   Consulting on the issues of licencing of pharmaceutical and medical activities
•   Regulatory audits for the identification of potential risks
•   Arranging workshops for the company’s preparation for audits, performing mock audits, participating in audits
•   Legislation (drafting amendments into normative legal acts, support in the elaboration of GOSTs, etc.)

Medicine and healthcare
•   Introducing innovative medicines provision models
•   Supporting market access strategies for pharmaceutical companies (price registration, inclusion on lists, etc.)
•   Comprehensive support of any form of public-private partnership projects (PPP, concession agreements, SPICs, offset agreements, lifecycle contracts)
•   Compulsory medical insurance
•   Operations of private and public healthcare providers
•   Non-commercial healthcare organisations (charities, etc.)

Comprehensive digital healthcare projects
•   SaMD (Soft as a medical device) and AI in healthcare
•   Legal support of telemedical healthcare projects
•   Big data: consulting on personal data protection, drafting policies, etc.
•   Preparation for and support of transactions with software, technology due diligence

Transactions with pharmaceutical and technological assets
•   Due diligence of target companies and assets, structuring transactions in view of the industry’s specifics and special requirements
•   Supporting M&A transactions: drafting transaction documents (SHA, SPA, Call-Option, Put-Option, Default-Option etc.), obtaining approvals from the FAS of Russia
•   Advising on antitrust compliance in the preparation for M&A transactions
•   Support at all stages of negotiations and at the closing
•   Comprehensive legal support of incorporation of legal entities (including pharmaceutical JVs), as well as branches and representative offices
•   Corporate law

Practices