Pharmaceuticals, Healthcare and Medicine
Pharmaceuticals legal advice, as well Healthcare, is оne of the priority practice of our firm. In particular, our expertise covers such areas as pharmaceuticals, biotechnologies, medical products, clinical trials of medicines and medical products, medical services. We are trusted by the companies representing the pharmaceutical industry, medical products, consumer goods, medicine, veterinary medicine, cosmetics, parapharmaceuticals, chemistry, biotechnology, agriculture and food products. Our firm is focused on the needs of the client and that is why we are involving lawyers from other practices, including intellectual property, corporate, tax and customs law, for the purpose of a comprehensive consultation.
- Consulting on all aspects of quality control of pharmaceutical products
- Consulting on prices and mark-ups regulation, participation in public procurement procedures
- Consulting on registration of original, generic medicines, biosimilars, orphan drug
- Legal advice on advertising and other promotion types for medicinal products, medical devices, cosmetics
- Legal advice on powers and legal support by inspections of law enforcement or supervisory authorities
- Legal advice on public procurement of medicinal products and medical devices
- Legal advice on regulatory issues of the pharmaceutical business (pricing, licensing terms etc.)
- Legal support in the field of intellectual property for medicines
- Legal support in the import of medicinal products, medical devices, cosmetic products
- Representation before all court instances on any disputes.
- Obtaining permit for transactions related to the acquisition of a network of medical laboratories in Ukraine.
- Legal support to the private equity investment fund having over USD 1 billion of assets under management, on acquisition of chain of medical centers, a leading private healthcare and insurance service provider in Ukraine. SDM Partner’s advice included full legal due diligence, structuring the transaction, drafting sale and purchase agreement and its negotiation with sellers.
- Legal due diligence in respect to acquisition of 30% of assets by Ukrainian pharmaceutical company
- Successful representation of the Ukrainian retail chain of pharmacies in connection with the claims of the Antimonopoly Committee of Ukraine about the overpriced prices
- On-going support for our clients in terms of licensing and permits including the sphere of medicine, alcohol, gambling, comical production, logistics, etc
- Legal support to the medical centers on regulatory & compliance, contractual aspects of conducting clinical trials in Ukraine, as well as further due diligence in respect to corporate structure and compliances, IP, assets, litigation and penalties.
- Legal advice on an M&A transaction aimed at the acquisition of a group of Ukrainian pharmaceutical companies, including conducting full legal due diligence and preparing transactional documentation.
- Legal support to the global innovative pharmaceutical giant on regulatory & compliance, contractual aspects of conducting clinical trials in Ukraine, as well as further due diligence in respect to corporate structure and compliances, IP, assets, litigation and penalties.
- Legal support to one of leading world pharmaceutical companies regarding organization and implementation of due diligence review of contracting parties.
- Mykola Melnyk and Dmytro Syrota have won the litigation against the tax inspectorate for a major Swiss medical company in relation to permanent establishment dispute
- Advice and service a foreign healthcare company regarding options for several intercompany finances of its Ukrainian businesses
- Represent the Ukrainian chain of medical laboratories concerning the Antimonopoly Committee of Ukraine claims on unreasonably high prices
- Full support of the European healthcare company in the process of the acquisition of a major Ukrainian artificial fertilization clinic.