Healthcare & Pharmaceutical Law
The healthcare and pharmaceutical sector is among the fields requiring specialized expertise due to its rapid growth, intensive R&D investments, and strict regulatory framework. For companies operating in this dynamic environment, accurate risk analysis and effective legal consultancy are of critical importance for sustainable success.
Operating under the leadership of Bilge Aydın Temiz, who has many years of experience in the healthcare sector and academic studies in the field of Healthcare Law, the team of Vona Law Firm provides legal services to national and international companies as well as individual clients in a wide range of areas, particularly reference pricing, clinical trials, pharmaceutical patents, healthcare reforms, and relations with public authorities, which constitute the largest purchasers in the pharmaceutical sector.
Healthcare and Pharmaceutical Law Consultancy
- Legal consultancy within the scope of patient and physician rights, sectoral requirements, and market regulations
- Management of compliance processes with healthcare legislation and regulatory authorities
Pharmaceutical and Medical Device Agreements
- Drafting of agreements for raw material purchase and sale, pharmaceutical manufacturing, hazardous waste management, and packaging recycling
- Commercial agreements specific to the pharmaceutical and medical device sectors
Clinical Trials and Marketing Authorization Processes
- Management of Healthcare Law and Pharmaceutical Law processes within the scope of clinical trials for pharmaceuticals and medical devices
- Monitoring of marketing authorization and registration processes
Dispute Resolution and Litigation
- Disputes between patients, physicians, and hospitals
- Lawsuits arising from medical malpractice
- Follow up on legal disputes between private healthcare institutions and insurance companies
Patents, Licensing, and Technology Transfer
- Pharmaceutical patents, counterfeit drugs, technology transfer, joint research, and cooperation agreements
- Protection of intellectual and industrial property rights
Share Transfers and Mergers
Management of legal processes related to the transfer of companies, together with product licenses to other companies during share transfer transactions
Consultancy Before Public Authorities and Regulatory Bodies
- Legal representation before ministries and other regulatory authorities
- Providing legal opinions to clients regarding amendments to legislation on pharmaceutical clinical trials
By Way of Example;
- Managing the legal process for the transfer of more than 50 products belonging to Roche Müstahzarları Sanayi A.Ş., together with their licenses, to other companies
- Providing training on Pharmaceutical Law and the Responsibilities of Pharmacists to 100 pharmacists, at the initiative of the Ankara Chamber of Pharmacists
- Participating, as the representative of Roche Müstahzarları Sanayi A.Ş., one of the leading companies in the sector, in legislative processes related to the Regulation on Clinical Trials of Pharmaceuticals and Biological Products, Regulation on Promotional Activities of Human Medicinal Products, Regulation on the Licensing of Human Medicinal Products, and Medical Devices Regulation
- Managing the sale of Zoleant A.Ş. (veterinary pharmaceuticals) to the Spanish company Labiana
- Ensuring the completion of the sale process of a specially regulated pharmaceutical manufacturing facility belonging to a sector-leading international client in full compliance with applicable legislation