We advise clients on the requirements and procedure for marketing authorizations issuance, transfer, revalidation and related issues for both medicines and medical devices. In addition, we provide advisory services relating to all other regulatory aspects of pharmaceuticals manufacture and trade.

We advise our clients, including both pharmaceutical companies and clinical research organizations, in all aspects of clinical trials and assist them in initiation and conduct of the procedure for obtaining clinical trial approvals. In addition, we draft all agreements relevant for clinical trial management and performance such as the agreements necessary with engaged health professionals and with health institutions where clinical trials are to be undertaken.

We provide our clients with wide-ranging advisory services regarding the relationship between pharmaceutical companies, on the one side, and healthcare professionals and the general public, on the other, such as the issue of health professionals engagement in promotional activities of pharmaceutical companies or the sponsorship of conferences and similar educational events as well as sponsorship of health professionals for the purpose of attending such educational events, or issues of pharmaceutical donations and advertising to the general public.

Working with our intellectual property department, we provide complete legal assistance with respect to clients' intellectual property right realization and protection, from intellectual property registration, licensing and assignment to the issues of intellectual property exploitation and enforcement in cases of counterfeit or other IP infringement made by third parties. We prepare all the necessary documents relevant for initiating and conducting the respective procedure (such as industrial property registration applications, agreements on intellectual property rights transfer, licensing and franchising, lawsuits) and represent you before all relevant authorities (such as customs authorities, Intellectual Property Office, the courts).

We manage the process of acquisition of companies engaged in the field of pharmaceutical law including pharmaceutical manufacturers, wholesalers and clinical research organizations. We also provide these services with respect to acquisition of privately owned health institutions (such as pharmacies or hospitals).

Clearly an important factor in the industry, we provide comprehensive advisory services with respect to the legal framework for public procurements and assist in the conduct of public procurement procedures. We also prepare and submit requests for the correct protection in cases when the public procurement procedures were not carried out in accordance with the law.

We advise on all aspects of food supplements and cosmetics regulatory and commercial issues, including requirements for their importation and issues with respect to their health regulation, labeling and distribution. In addition, with respect to product importation, we conduct the complete procedure before the Serbian Agency for Medicines and Medical Devices and the Faculty of Pharmacy in order to obtain certificates on product classification whenever such certificates are necessary for the product importation.

We advise on the organization and functioning of the health protection system, in particular with respect to the foundation of health institutions and private practice, regulatory requirements for their organization and work (such as the requirements with respect to their personnel, premises, equipment) and possibilities for their acquisition. We also assist in carrying out all relevant procedures, such as health organization foundation procedure, before the relevant state authorities (such as the Ministry of Health, commercial courts and the Serbian Agency for Business Registers). In addition, we provide advisory services with respect to the health institutions' accreditation in the procedure before the relevant Agency.

Although a new area, we advise on aspects of the healthcare system from the perspective of patients' rights enforcement in the case of medical negligence. In cooperation with our litigation department, we provide legal assistance relating to actual possibilities and limitations for obtaining remuneration for damage suffered due to medical negligence. In addition to contractual and tort liability, we provide advisory services with respect to criminal liability of health professionals (such as liability when providing medical treatment unconscientiously or refusing to provide medical assistance to the patients).

We advise insurance clients on private health insurance and requirements which insurance companies have to fulfill in order to be able to provide this type of insurance service. Furthermore, our advisory services in the area of health insurance include advising on the possibilities for health institutions and the doctors themselves to obtain professional liability insurance.