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Life Sciences

Our unparalleled expertise in legal developments concerning the life sciences sector, predating Romania’s accession to the European Union in 2007, has made us the go-to advisors for our clients. With our in-depth industry knowledge, we provide reliable advice, enabling our clients to make informed decisions on legal, compliance, and operational matters.

The medical device industry has been experiencing rapid development in emerging technologies. This has led to the creation of exciting and innovative products that benefit patients all over the world. However, legislators often face difficulties in keeping up with the pace of technology, leading to increased challenges in the sector. We have a unique approach that has been honed through years of experience, which allows us to navigate these challenges successfully. This sets us apart as a valuable partner in the industry.

Our work focuses 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

Integration, a distinctive trail of our services

Complementing all technicalities specific to the life sciences sector, we are highly aware of the fact that there are also commercial drivers that will influence pricing and advertising campaigns, R&D and collaboration agreements, corporate restructuring and financing, asset purchases, or potential M&As. Thanks to our deep sector knowledge, we are well equipped to offer strategic solutions and insight, as well as provide a sense of forward-thinking, anticipation and readiness.

Practicality and consistency across the table

Our firm has been keeping a close eye on the dynamic developments in the field of medicinal cannabis, which is one of the most significant topics in the pharmaceutical industry. We have been observing these developments across the globe for many years, including in jurisdictions where medicinal cannabis is regulated and prescribed, as well as in jurisdictions with more restrictive regulatory regimes. Our integrative perspective, combined with our commitment to staying abreast of the latest developments, ensures that we can provide our clients with the most up-to-date and relevant legal counsel. With our extensive experience, we are well-prepared and agile enough to guide our clients through the complex and evolving legal and regulatory aspects of the medicinal cannabis industry.

We are committed to supporting our clients in this new legal landscape, both in Romania and worldwide, thanks to our close cooperation to reputable peers active in this industry. We are always ready to adapt to the changing needs of this industry.

Who turns to us?

Our clients come from a variety of backgrounds, ranging from start-ups to multinational corporations. Regardless of their size, all businesses that are directly or indirectly linked to the life sciences industry face certain risks and can benefit from numerous opportunities.

These risks and opportunities can stem from a variety of factors, including intellectual property rights, regulatory and compliance issues, marketing and advertising restrictions, data protection, and product liability concerns. Moreover, with the increasing use of mobile and interconnected devices, new challenges are emerging in terms of security and medical device vulnerabilities.

Our practice is well-equipped to provide comprehensive support in all of these areas.