Life sciences and health care industries are among the most heavily regulated ones globally. Tackling the complexities of the regulatory regimes is no easy task, from the stage of obtaining marketing authorization to that of commercialisation. Successfully competing in such environment requires a legal partner with a creative, comprehensive approach, and a global perspective. In the specific context of Serbia, Montenegro and Bosnia and Herzegovina, the ability to provide reliable legal advice in life sciences and healthcare matters rests on an in-depth understanding of the still unconsolidated national frameworks and the EU acquis which the prospective EU members are bound to implement.
Our team of dynamic and multi-lingual lawyers has specialized at the leading European universities on the topics of regulation in life sciences and healthcare. We have advised leading multinational pharmaceutical companies on a range of commercial and regulatory issues. Combined with our legal and technical expertise, this enables us to provide practical and creative advice on how to successfully navigate the evolving national and EU legal frameworks to achieve successful outcomes for our clients. We are supported by the SEE Legal, through which we have access to know-how and market intelligence from twelve jurisdictions in the South East Europe region. The network enables us to deliver a seamless service to multinational clients through coordinated multi-jurisdictional legal advice.
The list of our references is available upon request.
Our areas of work include:
Incorporation, development and financing of pharmaceutical companies, pharma wholesalers, clinics and hospitals
Mergers & acquisitions, including competition matters
Protection and maximization of IP rights
Marketing authorizations and labelling of medicines
Advertising and interaction with healthcare professionals
Off-label use of medicines
Healthcare subscription schemes
Litigation in product liability, trade mark and patent disputes