Pharmaceutical Regulation and Pharmaceutical ComplianceThe Medical and Reproductive Law Center provides expert and analytical support in the field of pharmaceutical regulation, pharmaceutical compliance and the legal aspects of healthcare and pharmaceutical activities.
The Center's work includes legal and regulatory issues related to pharmaceutical business activity, healthcare and pharmaceutical regulation, licensing procedures, contractual documentation, regulatory compliance, intellectual property, healthcare marketing and legal aspects of the circulation of medicinal products and healthcare products.
The Center cooperates with pharmaceutical companies, pharmacy chains, distributors, healthcare organisations, healthcare projects and other participants of the pharmaceutical and healthcare sectors.
Key areas of expertise include: - pharmaceutical regulation;
- pharmaceutical licensing;
- regulatory compliance;
- legal aspects of medicinal products circulation;
- contractual and commercial legal support;
- healthcare and pharmaceutical marketing regulation;
- legal support for clinical research and clinical trials;
- intellectual property protection;
- legal aspects of cooperation with healthcare institutions;
- legal due diligence of pharmaceutical and healthcare projects.
Particular attention is devoted to international regulatory issues in the healthcare and pharmaceutical sectors, as well as to the analysis of contemporary legal, regulatory and ethical challenges related to medicinal products, healthcare products and healthcare governance.
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