Healthcare and Life Sciences

Regulatory Compliance and Licensing

We advise pharmaceutical, medical device, biotechnology, and healthcare companies on licensing, marketing authorizations, and compliance with regulations issued by the Turkish Medicines and Medical Devices Agency (TITCK). Our work covers product classification, labeling, promotional rules, pharmacovigilance obligations, and the implementation of ongoing compliance programs.

Clinical Trials and R&D

We work with sponsors, contract research organizations (CROs), and research institutions to support the planning and execution of clinical trials in Turkey. Our counsel includes obtaining regulatory approvals, preparing ethics committee submissions, drafting informed consent forms, and ensuring compliance with data protection requirements.

Market Access and Pricing

Our team advises on price approvals, reimbursement processes, and relations with the Social Security Institution (SGK) and other authorities. We assist companies in designing market entry and access strategies, providing guidance on health technology assessments (HTAs), reference pricing, and managed entry agreements.

Commercial Agreements and Distribution

We draft, review, and negotiate license, distribution, co-marketing, clinical supply, and manufacturing agreements for pharmaceutical, medical device, and biotechnology products. Our work includes solutions that comply with sector-specific competition rules, anti-corruption legislation, and data privacy laws.

Intellectual Property Protection in Life Sciences

We advise life sciences companies on securing, enforcing, and commercializing their intellectual property rights. We provide support on patent litigation for both originator and generic drug manufacturers, data exclusivity strategies, supplementary protection certificates, and brand and product protection.

Product Liability and Disputes

We represent our clients in disputes arising from defective products, product recalls, regulatory sanctions, and liability lawsuits. Our interdisciplinary approach combines litigation, crisis management, and compliance enhancements to control risks and protect corporate reputation.