Healthcare and pharmaceutics
Legal services to pharmaceutical companies and other organizations of the pharmaceutical industry, manufacturers and distributors of medical devices (medical equipment), manufacturers and distributors of dietary supplements
BRACE Law Firm, within the framework of the “Healthcare and Pharmaceutics” practice, provides legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law. The main directions of the provision of legal services are 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.
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, manufacturers and distributors of medical products, pharmacy chains, as well as organizations engaged in the sale and production of cosmetic products and dietary supplements. Our clients are both residents and non-residents, as giants included in the Big Pharma group, as well as medium and small Russian and foreign companies.
The activities of both Russian and foreign pharmaceutical companies and companies engaged in the circulation of medical devices are governed by both general rules of law for all legal entities and special laws relating to the circulation of medicines and medical devices. Because these goods have their specifics and uniqueness, the current legislation establishes the specifics of the legal regulation of their circulation in the market.
Certain legal issues may arise in almost every business entity participating in the circulation of medicines and medical devices. Moreover, often, 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 Law Firm conducts active research, takes part in the activities of the Center for the Study of the Normative Environment of Pharmaceuticals and Biotechnology.
Besides, we carry out specialized events for pharmaceutical industry employees, as well as in researching regulatory issues in pharmaceuticals and healthcare, the results of which are published in leading pharmaceutical journals. Our experts regularly monitor changes in legislation and law enforcement practices, the results of which are reflected in monthly digests.
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, an understanding of the functioning of the legal system, individual and partnership relations with each client, compliance with high professional and ethical standards, and technological effectiveness in working with information.
- 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 medical devices business)
- 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 of interaction with medical and pharmaceutical workers
- Legal support of public-private partnership projects in healthcare and pharmaceuticals