Pharmaceutical and Healthcare Regulatory
ELIG Gürkaynak provides legal consultancy to a wide range of sectors including healthcare, pharmaceutical, medical device and life-sciences companies in their day-to-day operations, regulatory issues and contracts. Our dedicated team provides legal advice to healthcare and pharmaceutical clients on matters relating to re-structuring, licensing, intellectual property, management of sector related transactions and regulatory and governmental issues.
We closely monitor developments in the Turkish regulatory environment triggered by government agencies and inform and assist our clients so that they may adapt and benefit from the changes in legal and regulatory areas.
Our team of attorneys has extensive experience with the standards, principles, forms and requirements of various Turkish healthcare institutions such as the Ministry of Health, the Medicines and Medical Devices Agency and the Social Security Institution.
The support offered by ELIG Gürkaynak extends to a wide range of areas including all aspects of the regulation of pharmaceuticals, medical devices, cosmetics, pharmacies, hospitals, healthcare professionals, and pricing, promotion, labeling, safety, advertising and marketing principles of medicines and medical products. We guide our clients through numerous complex guidelines and practices of the Ministry of Health, for example, compassionate use, procurement from abroad, scientific and product promotional meetings, Good Distribution Practice (GDP), Good Manufacturing Practice (GMP), samples, adverse effects, pharmacovigilance, clinical research and donations.
Using our renowned expertise in competition law, M&A, anti-corruption, employment, intellectual property, dispute resolution, public procurement and administrative law, we ensure our clients receive high quality legal advice and assistance throughout the entire business cycle of a life sciences and healthcare product or service.