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office@simionbaciu.ro

Life Sciences

Having been at the forefront of the legal developments even before Romania having joined the European Union, back in 2007, our in-depth industry knowledge convinced our clients to rely on our advice when making informed decisions from a legal, compliance and operational perspective.

Our multidisciplinary team of lawyers advises clients on all aspects of the business cycle of a life science and healthcare product or service, from development to protection of intellectual property and further on to exploitation.

Rapid development of emerging technologies in the medical devices sector has brought new and exciting products to market to the benefit of patients around the world. However the legislators sometimes face difficulties in keeping pace with the technology speed, this leading to the sector facing increased challenges, which we are perfectly equipped to help navigate.

Whether a start-up or a multinational corporation, all businesses are impacted by risks, and benefit from opportunities, arising from intellectual property rights, regulatory and compliance issues, marketing and advertising restrictions, data protection or product liability. The increasing use of mobile or interconnected devices raises new challenges in terms of security and vulnerabilities of medical devices.

We have and continue to closely monitor the developments in the area of medicinal cannabis, one of the hottest topics in the pharmaceutical industry. We watch developments in countries across the globe for many years, including in jurisdictions where medicinal cannabis is regulated and prescribed or many years, as well as jurisdictions where the regulatory regime is more restrictive.

We are now experienced enough to help our clients navigate the complex and evolving legal and regulatory aspects impacting this new industry, as part of the future legal landscape, both in Romania and worldwide.

Finally, there are also commercial drivers which will influence pricing and advertising campaigns, R&D and collaboration agreements, corporate restructuring and financing, asset purchases or potential M&As. All of this requires lawyers with deep sector knowledge who can offer strategic solutions and insight.

We dare say, we have the necessary expertise and can advise you on:

  • clinical trials;
  • corporate transactions;
  • data privacy, data protection & cybersecurity;
  • donation and sponsorship agreements;
  • distribution of medicinal products and medical devices;
  • e-health, m-health and digitalization;
  • license and supply agreements;
  • marketing arrangements and advertising
  • parallel imports;
  • patent and trademark disputes and IP strategy;
  • pricing of medicinal products, including claw-back;
  • product liability;
  • R&D collaborations;
  • regulatory and data exclusivity;
  • technology transfers and IP Licensing.