Preparation and legal examination of contracts for pharmaceutical activities and activities in the field of circulation of medical devices

Amendments to the registration documents of medical devices

One of the important areas of legal services of the practice “Healthcare and Pharmaceutics” of BRACE Law Firm is the development and legal examination of contracts in the implementation of pharmaceutical activities in the field of circulation of medical devices.

BRACE Law Firm provides legal services to manufacturers and distributors of pharmaceutical products, medical devices, dietary supplements and other healthcare organizations on issues of Russian and international law. We provide legal assistance in the areas of legal support of commercial activities, dispute resolution and litigation, public and corporate procurement, antitrust law, international trade law and compliance.

The development and legal examination of contracts/contracts in the field of pharmaceuticals and the circulation of medical devices is one of the key areas of work of BRACE Law Firm.

Preparation and legal examination of contracts in order to support the contracting

activities of pharmaceutical companies

The work of pharmaceutical companies, as well as organizations involved in the circulation of medical devices, has its own specifics and is regulated by the rules of special legislation, which are mandatory for accounting when developing certain types of contracts.

The most common contracts for pharmaceutical activity include distribution and supply contracts, licensing agreements, agreements on the alienation of exclusive rights, contracts for the conduct of clinical trials, rental contracts for equipment and premises, agency contracts, contracts for scientific events and others.

In particular, treaties governing the distribution, promotion, advertising of medicines and medical products have their own characteristics. When concluding them, it is important to take into account the special requirements of the legislation on advertising, as well as the particularities of the circulation of medicines and medical devices.

In addition, special relevance and important specificity are inherent in contracts for scientific research, as well as clinical and other expert studies aimed at introducing drugs and medical devices into circulation. The most important factor for observing the intellectual property rights of manufacturers of medicines and medical devices is the detailed elaboration of license agreements, as well as the conditions for protecting intellectual property rights as part of the conclusion of supply, agency and other agreements.

Often, full-time specialists of business entities do not always have the opportunity to timely and comprehensively assess the legal risks of concluding a contract taking into account all the features of the activities of pharmaceutical companies and organizations involved in the circulation of medical devices, as well as defend their position in the process of negotiating with contractors. In such a situation, the most optimal solution to the problem would be to attract professional lawyers specializing in the specified legal field to accompany the contractual work.

Legal services

    1. Legal advice on issues related to the development of contracts for pharmaceutical activities and activities in the field of circulation of medical devices
    2. Development of contracts, as well as standard contract templates to create conditions for clients to build further independent contractual work
    3. Legal analysis of the submitted contracts for compliance with the requirements of the law, including legislation in the field of circulation of medicines and medical devices
    4. Preparation of conclusions on existing legal risks, preparation of protocols of disagreements and development of proposals to protect the interests of the client
    5. Representation of interests of clients when negotiating with contractors
    6. Subscription services in the field of contract work of pharmaceutical companies and manufacturers of medical devices

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Conclusion of legal services agreement
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