Legal support of activities of pharmaceutical companies
BRACE Law Firm within the practice “Healthcare and Pharmaceutics” provides legal services for the legal support of pharmaceutical companies, including manufacturers and distributors of drugs and pharmaceutical substances.
The key clients of BRACE Law Firm are concentrated in the healthcare and pharmaceutical sectors. Providing legal services in this area, we cooperate with pharmaceutical companies, pharmacy chains, as well as other pharmaceutical business companies. Our clients are both residents and non-residents, as giants included in the “Big Pharma”, as well as medium and small Russian and foreign companies.
We provide quality, effective and timely solutions. In each case, the BRACE team strives to ensure that the best result is achieved with the least possible means. The quality of our services is based on industry expertise, understanding of the specifics of the functioning of the legal system, individual and partnership attitude to each client, compliance with high professional and ethical standards, technological effectiveness in working with information.
BRACE Law Firm conducts active research, takes part in the activities of the Center for the Study of the Normative Environment of Pharmaceuticals and Biotechnology of the Law Faculty of the National Research University Higher School of Economics.
In addition, we conduct specialized events for employees of the pharmaceutical industry, as well as in conducting research on regulatory issues in pharmaceuticals and healthcare, the results of which are published in leading pharmaceutical journals. Our experts regularly monitor changes in Russian legislation and law enforcement practices, the results of which are reflected in the relevant analytics.
Russian pharmaceutical industry is quite complicated from the point of view of legal regulation, because it carries with it complex industry issues of pharmaceuticals, which are not always able to fit into the usual legal structures. This specificity requires lawyers in the pharmaceutical field to have a high level of qualification and the availability of specialized knowledge, both in the field of pharmaceuticals and in the field of legal support for the pharmaceutical business.
The Russian legislation on the circulation of medicines establishes the unconditional priority of state regulation of the circulation of medicines and pharmaceutical substances, which indicates the particular importance of these relationships for society and the state. So, for example, one of the main issues regulated by pharmaceutical law is the registration of medicines, which is fundamentally different from the state registration of all other objects, since it is directly related to the health and life of patients, which determines the priority of state regulation.
The legal regulation of pharmaceuticals should ensure, first of all, the protection of the rights of consumers of medicines, increasing their quality and safety, accessibility and balanced price regulation, public procurement of medicines, as well as other aspects related to public and private interests.
The activities of both Russian and foreign pharmaceutical companies are governed by both general rules of law for all legal entities and special laws relating to the circulation of drugs and pharmaceutical substances. Taking into account the fact that these goods have their own specifics and uniqueness, the current legislation establishes the specifics of the legal regulation of their circulation on the market.
Certain legal issues may arise in almost every business entity involved in the circulation of drugs and pharmaceutical substances. Moreover with the development of international relations, the legal relations of these companies are complicated by a foreign element. Solving a large volume of diverse legal issues can be very difficult without the provision of qualified legal assistance.
BRACE lawyers specializing in pharmaceuticals area with a wide variety of legal issues related to the handling of drugs and pharmaceutical substances. In cases where there is a need for industry expertise, we resort to both our experts and partners of the company, who are recognized experts in the pharmaceutical industry.
The main directions of the provision of legal services is legal assistance in the areas of supporting commercial activities, resolving disputes and litigation, public and corporate procurement, regulatory issues in the field of healthcare, compliance, antitrust law and international trade law.
- Legal support of pharmaceutical companies
- Legal support for manufacturers and distributors of medical devices
- Legal advice on the circulation of drugs, medical devices, dietary supplements
- Compliance on issues related to the activities of pharmaceutical and medical product companies
- Legal support in public procurement in healthcare
- Development and legal examination of contracts (in the implementation of pharmaceutical activities and activities in the field of circulation of medical devices)
- Development and legal examination of internal policies (anti-corruption, antitrust, and others) for pharmaceutical companies and companies in the field of medical products
- Legal advice on the protection of personal data in the field of healthcare
- Legal support for the promotion of drugs, medical devices, dietary supplements
- Consulting during inspections (pharmaceutical companies and companies dealing with the circulation of medical devices)
- Advocacy against unfair competition
- Legal advice on the formation of lists of medicines
- Legal advice on state registration and re-registration of drug prices
- Preparation of draft licensing agreements and agreements on the alienation of exclusive rights
- Legal support for the development of medicines and medical products, dietary supplements
- Legal support of manufacturing of medicines, medical products and dietary supplements
- Legal support of clinical and preclinical studies
- Advice on the import / export of medicines, medical products, dietary supplements
- Legal support of technology transfer deals in healthcare and pharmaceuticals
- Legal support of investments in healthcare and pharmaceuticals
- Legal support for the distribution of medicines, dietary supplements and medical devices
- Legal support for interaction with healthcare professionals, medical and pharmaceutical workers
- Legal support of public-private partnership projects in healthcare and pharmaceuticals