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Healthcare and Lifescience
VERBA LEGAL's pharmaceutical and healthcare practice fulfills all legal requirements for the pharmaceutical industry, medical device producers, distributors, pharmacy networks, private medical firms, digital health entities, and leading FMCG conglomerates.
Pharmaceuticals and Healthcare
VERBA LEGAL's pharmaceutical and healthcare practice fulfills all legal requirements for the pharmaceutical industry, medical device producers, distributors, pharmacy networks, private medical firms, digital health entities, and leading FMCG conglomerates.
The practice excels in comprehensive legal matters concerning the distribution of pharmaceuticals, medical devices, and FMCG products, dealings with pharmaceutical assets of any type, data privacy and management, and the development of industrial compliance systems.
Our team of over 20 specialists boasts the market's most extensive industry-specific expertise.
Among our clientele are more than 80% of the largest international and Russian pharmaceutical companies. They supply over 50% of the Russian pharmaceutical market. Our experts have implemented over 1,000 projects for industrial clients in the last few years.
Our practice ranks in band 1 of the Pravo-300 rating. Our attorneys are acknowledged in individual rankings such as Pravo-300, Chambers Europe, and Best Lawyers.
Practice leader Alexander Panov is also part of the Health Care Committee's expert council within the Federation Council.
The practice excels in comprehensive legal matters concerning the distribution of pharmaceuticals, medical devices, and FMCG products, dealings with pharmaceutical assets of any type, data privacy and management, and the development of industrial compliance systems.
Our team of over 20 specialists boasts the market's most extensive industry-specific expertise.
Among our clientele are more than 80% of the largest international and Russian pharmaceutical companies. They supply over 50% of the Russian pharmaceutical market. Our experts have implemented over 1,000 projects for industrial clients in the last few years.
Our practice ranks in band 1 of the Pravo-300 rating. Our attorneys are acknowledged in individual rankings such as Pravo-300, Chambers Europe, and Best Lawyers.
Practice leader Alexander Panov is also part of the Health Care Committee's expert council within the Federation Council.
Services
Transactions with pharmaceutical assets
Full-scale support for legal and financial due diligence of target companies and/or assets.
Transactional structure development based on the regulatory specifics common to pharmaceutical assets, preparation of a risk map and a mitigation negotiation strategy.
Drafting transaction documents of any complexity level.
Full legal support for the negotiation process, including completion of the transaction.
Legal advice on obtaining FAS consent to transactions.
Tax structuring for transactions involving pharmaceutical assets.
Transactional structure development based on the regulatory specifics common to pharmaceutical assets, preparation of a risk map and a mitigation negotiation strategy.
Drafting transaction documents of any complexity level.
Full legal support for the negotiation process, including completion of the transaction.
Legal advice on obtaining FAS consent to transactions.
Tax structuring for transactions involving pharmaceutical assets.
Legal issues of drug and medical device development
Structuring of contractual relations in the framework of research and development of medicinal drugs and medical devices.
Protection of IP created in the course of development of medicinal drugs or medical devices, full advice on commercialisation of same (disposal of exclusive rights, licensing, etc.).
Legal support for current operational matters of biotechnological venture funds and Life Sciences start-ups.
Protection of IP created in the course of development of medicinal drugs or medical devices, full advice on commercialisation of same (disposal of exclusive rights, licensing, etc.).
Legal support for current operational matters of biotechnological venture funds and Life Sciences start-ups.
Preclinical and clinical trials of medicines, trials of medical devices
Contractual models of any complexity level developed in the framework of preclinical and or clinical studies of medicinal drugs, and trials of medical devices.
Drafting of, and full support for, any contracts entered into in connection with preclinical and/or clinical studies of medicinal drugs, and trials of medical devices.
Development of legal models for handling patient data in the course of studies, including non-standard study designs; legal advice on RWE studies.
Advising companies on most tricky regulatory matters of studies and trials of medicinal drugs and medical devices, including searches for solutions in non-standard situations and for new approaches to research-connected industry challenges.
Drafting of, and full support for, any contracts entered into in connection with preclinical and/or clinical studies of medicinal drugs, and trials of medical devices.
Development of legal models for handling patient data in the course of studies, including non-standard study designs; legal advice on RWE studies.
Advising companies on most tricky regulatory matters of studies and trials of medicinal drugs and medical devices, including searches for solutions in non-standard situations and for new approaches to research-connected industry challenges.
Legal support of commercial relations of pharmaceutical and medical devices market participants
Drafting, revision, and support of any contracts for commercial operations of the industry companies, from simple to most complex.
Client representation in negotiating commercial contracts of any complexity level.
Preparation of commercial policies, policies for working with pharmacy chains, including complicated cases like different counter-party categories, etc.
Development of bonus models for clients’ relations with their counter-parties, advice on antitrust and tax risks of bonus relations.
Advice on development of marketing strategies for clients’ relationships with pharmacy chains.
Legal support for licensing of pharmaceutical operations.
Assistance with development of quality management systems at any stage of the drug or device life cycle, including drafting from scratch or revision of the required SOP, contracts, instructions, and other documents.
Advice on public-private partnership projects in the Life Sciences industry (PPP, concession agreements, special investment contracts, offset contracts, life-cycle contracts).
Advice on state procurement of medicinal drugs and medical devices.
Advice on consumer law, including support for consumer disputes.
Client representation in negotiating commercial contracts of any complexity level.
Preparation of commercial policies, policies for working with pharmacy chains, including complicated cases like different counter-party categories, etc.
Development of bonus models for clients’ relations with their counter-parties, advice on antitrust and tax risks of bonus relations.
Advice on development of marketing strategies for clients’ relationships with pharmacy chains.
Legal support for licensing of pharmaceutical operations.
Assistance with development of quality management systems at any stage of the drug or device life cycle, including drafting from scratch or revision of the required SOP, contracts, instructions, and other documents.
Advice on public-private partnership projects in the Life Sciences industry (PPP, concession agreements, special investment contracts, offset contracts, life-cycle contracts).
Advice on state procurement of medicinal drugs and medical devices.
Advice on consumer law, including support for consumer disputes.
Advertising, promotion, and market access in the pharmaceutical and medical device industries
Review of marketing materials for compliance with the applicable law.
Advice on Internet advertising.
Drafting promotion agreements of any type and complexity.
Legal support for inclusion of medicinal drugs in the public healthcare system (price registration, listing, development of complex market access strategies, such as sharing and other models, etc.).
Claim management and litigation related to advertising of medicinal drugs, medical devices, and consumer goods.
Advice on Internet advertising.
Drafting promotion agreements of any type and complexity.
Legal support for inclusion of medicinal drugs in the public healthcare system (price registration, listing, development of complex market access strategies, such as sharing and other models, etc.).
Claim management and litigation related to advertising of medicinal drugs, medical devices, and consumer goods.
Compliance
Development and legal implementation of any corporate compliance processes (interaction with healthcare professionals, organisation of events, know-your counter-party procedures, etc.), including SOP preparation.
Advice on industry-specific sanctions compliance.
Building from scratch or revision of the industry-specific anti-corruption system, anti-corruption audit.
Industry-specific legal and compliance due diligence of counter-parties.
Support for compliance investigations.
Arrangement and conduct of compliance trainings for the client’s internal functions.
Market research on the industry compliance matters.
Legal support for industry innovations.
Advice on genetic research, including legal aspects of genetic information circulation, integration of genetic research in public healthcare, contractual structuring of relations in the field of genetics.
Legal support for digital healthcare projects, including telehealth technologies, digital health and well-being platforms.
Structuring of big medical data and AI projects in healthcare.
Advice on medical software and its circulation specifics.
Support in implementation of experimental legal structures for digital innovations.
Liaison with the governmental authorities.
Preparation of responses to inquiries, and advice on communication with the governmental authorities.
Making regular audits for early identification and mitigation of risks in the framework of preparation for inspections by the authorities.
Law-making activities in any industry areas (drafting of regulatory acts, representation in work groups, etc.).
Advice on industry-specific sanctions compliance.
Building from scratch or revision of the industry-specific anti-corruption system, anti-corruption audit.
Industry-specific legal and compliance due diligence of counter-parties.
Support for compliance investigations.
Arrangement and conduct of compliance trainings for the client’s internal functions.
Market research on the industry compliance matters.
Legal support for industry innovations.
Advice on genetic research, including legal aspects of genetic information circulation, integration of genetic research in public healthcare, contractual structuring of relations in the field of genetics.
Legal support for digital healthcare projects, including telehealth technologies, digital health and well-being platforms.
Structuring of big medical data and AI projects in healthcare.
Advice on medical software and its circulation specifics.
Support in implementation of experimental legal structures for digital innovations.
Liaison with the governmental authorities.
Preparation of responses to inquiries, and advice on communication with the governmental authorities.
Making regular audits for early identification and mitigation of risks in the framework of preparation for inspections by the authorities.
Law-making activities in any industry areas (drafting of regulatory acts, representation in work groups, etc.).
Project Experience
Comprehensive legal support for the development and international market launch of a Covid-19 vaccine (in over 70 countries), including drug registration, intellectual property rights management in these countries, structuring deals for production localization and technology transfer in over 20 jurisdictions, and full negotiation support with more than 50 international partners.
Developed a legal framework for a major cosmetics manufacturer to manage partner relationships under selective distribution agreements.
Structured and fully supported the execution of over 25 transactions involving drug portfolios, encompassing intellectual property rights transfer, regulatory compliance, antitrust considerations, and commercial structuring of pharmaceutical asset transactions.
Created a detailed legal guide for healthcare R&D organizations on medical technology transfers, applicable in more than 12 jurisdictions.
Formulated a commercialization strategy for genetic research in Russia, including a legal framework that maximizes client interests and mitigates associated risks.
Executed projects to establish commercial policies for pharmaceutical producers' interactions with distributors and pharmacy networks, incorporating advanced counterparty categorization strategies.
Managed the full preparation process for the client's largest special investment contract in Russia (RUB 6.25 billion), the most significant in the healthcare sector to date. This remains the largest special investment contract signed to date in the healthcare sector. The contract mandates the localization and manufacturing of blood-derived products.
Legal assistance in transforming the approach to conducting clinical trials of medications in Russia, including contract drafting and legal advice for the client's observational studies.
Prepared extensive legal analysis on the accessibility of state healthcare information systems for private companies aiming to leverage the data for analytical and research purposes.
Complete coordination of client's promotional activities, including the harmonization of advertising materials (TV, radio, online), materials for healthcare professionals, both promotional and educational (including a healthcare professional portal and corporate social media presence), and legal document preparation for respective platforms. Client support concerning internet advertising compliance and labeling.
Legal support for releasing an application on Russian and international markets designed to foster mindful health practices and timely medical consultations. Developed a data protection strategy within the application, identifying and mitigating associated content risks.
Provided comprehensive legal support for the development and global launch of a COVID-19 vaccine.
Addressed numerous complex regulatory challenges, facilitating the introduction of an innovative medical device in the Russian market.
Supported the operations of B2C online cosmetics stores and B2B medical devices e-commerce platforms.
Devised a legal framework for a cosmetics product manufacturer to manage partner relations under selective distribution agreements.
Formulated commercial strategies for pharmaceutical manufacturers to improve their distributor relations.
Offered complete legal support for the entire lifecycle of a COVID-19 medication, including technology transfer deals, production localization in more than 10 jurisdictions, drug registration across over 30 jurisdictions, and securing over 40 contracts with international partners.
Orchestrated more than 15 transactions for the transfer of drug portfolios, addressing intellectual property, pharmaceutical regulations, antitrust limitations, and commercial structuring.
Executed over 40 projects in production localization and developed a contractual model for collaboration between the holders of registration certificates, intellectual property rights for pharmaceuticals or medical devices, and the producers.
Who will be working with you
Our team
practices
See also
Regulatory and compliance advisory
Our practice offers holistic compliance services, ranging from basic risk assessment of partners to the development and implementation of comprehensive compliance frameworks for organizations.
Dispute Resolution
Our team represents clients in Russian courts and has extensive experience in handling complex cross-border disputes spanning multiple jurisdictions.
Capital markets, banking and financial law