Clinical trials in Turkey are in compliance with European Union regulations. The legal regulations, including the Regulation on Clinical Trials of Medicinal and Biological Products, the Regulation on Clinical Trials of Medical Devices, the Regulation on Clinical Trials and Studies of the Effectiveness and Safety of Cosmetic Products or Raw Materials, and the guidelines issued based on these regulations, are strictly followed by the Turkish Medicines and Medical Devices Agency and the Ministry of Health.
With its experience in managing clinical trial processes, Bozoğlu İzgi offers legal consultancy on matters such as clinical trial agreements, determining the parties and responsibilities of the agreements, ethical relationships with research institutions, ensuring transparency in the clinical trial process in compliance with relevant legal regulations, confidentiality of patient data, obtaining the necessary permits from authorized institutions and organizations, and other related matters.
Bozoğlu İzgi’s priority is ensuring compliance with regulations at every stage of the highly regulated clinical trials, preventing potential disputes before they arise, and ensuring that the process is conducted within the framework of “good clinical practices” while protecting the rights of volunteers. To achieve this, Bozoğlu İzgi provides qualified consultancy services by preparing form documents, contracts, and supporting documents that meet the regulatory requirements or reviewing existing documents and contracts during clinical trial processes.
Bozoğlu İzgi Attorney Partnership