Pharma

Our firm advises pharmaceutical companies, biotechnology firms, and medical device manufacturers on the full spectrum of legal and regulatory matters in Greece and the European Union. We possess extensive expertise in the applicable framework, including Greek legislation on clinical trials, the EU Clinical Trials Regulation, the Medical Device Regulation, and data protection requirements governing health data. Our work focuses on regulatory compliance, intellectual property protection, and market access, supporting clients in securing approvals from the National Organization for Medicines and navigating complex administrative procedures. We regularly advise on pricing and reimbursement frameworks, distribution arrangements, and strategic transactions within the life sciences sector, including mergers and acquisitions. Our experience combines technical regulatory knowledge with a strong understanding of the commercial and operational realities of pharmaceutical and healthcare markets.

We provide comprehensive legal support across the entire pharma and life sciences value chain, from research and development to commercialization and post-market activities. Our services include drafting and negotiating clinical trial agreements, licensing arrangements, and distribution contracts, as well as advising on compliance with advertising and promotion rules applicable to pharmaceutical products and medical devices. We assist clients in navigating data protection requirements for sensitive health data, ensuring full alignment with GDPR and national legislation. Our team also advises on market access strategies, including pricing and reimbursement procedures and negotiations with public healthcare authorities, enabling clients to effectively position their products in the Greek market. In addition, we provide robust support on intellectual property matters, including the protection and enforcement of patents, trademarks, and trade secrets, as well as representation in disputes involving IP infringement, product liability, and regulatory compliance.

Greece’s pharmaceutical and life sciences sector remains a key pillar of the national economy, supported by a well-established regulatory framework aligned with EU standards and a growing emphasis on innovation. The sector is benefiting from increased investment in research and development, particularly in areas such as biologics, biosimilars, and personalized medicine. At the same time, national and EU-level initiatives are accelerating the adoption of digital health solutions, including electronic prescription systems and data-driven healthcare services. Despite these positive developments, companies operating in Greece must navigate a demanding regulatory environment, including strict approval timelines, pricing and reimbursement constraints, and enhanced transparency obligations. These factors contribute to a complex but increasingly sophisticated market landscape.

Greece offers a range of opportunities for investment and growth in the pharmaceutical and life sciences sector, particularly in innovation-driven and technology-enabled areas. Key opportunities include the development and commercialization of biosimilars, advanced therapies, and digital health solutions, as well as the integration of artificial intelligence into clinical research and healthcare delivery. The country’s research ecosystem, supported by EU funding and national incentives, encourages collaboration between academic institutions, research centers, and industry stakeholders. In parallel, the expansion of e-health infrastructure and the continued digitalization of healthcare services create new avenues for market entry and growth. Greece’s strategic geographic position further enhances its attractiveness as a regional hub for life sciences companies seeking access to European and neighboring markets, reinforcing its role in a rapidly evolving global healthcare landscape.