FIELDFISHER
At Fieldfisher, we are a leading law firm in the provision of legal advice to companies of the Life Sciences sector, especially in the areas of regulatory, R+D+I and Tech&Data.
We provide a full range of services to the pharmaceutical, biotechnology and MedTech industry, including from assisting companies in their day-to-day business, advising them in market access matters, technology development agreements and collaboration agreements with different actors involved in the research system, clinical trials and other studies, and on all regulatory issues arising from the marketing of the products, to assisting and representing them in complex contentious proceedings before the public administration and the courts, as well as before the bodies of the sectoral codes of practice.
Furthermore, while the Life Science industry remains our focus, we have also developed an extensive expertise in other areas that we consider key for our practice, such as e-health, food supplements and veterinary sector.
We advise companies in the Life Sciences sector on:
1) R+D+I:
- Assessment of specific agreements and conventions for collaboration between the different agents in the research system, technology transfer, affiliation of research personnel, etc.
-Advice on specificities applicable to research personnel and the existing incompatibilities in the public sphere at both national and regional level.
-Support in relation to the processing of human biological samples for biomedical research purposes.
2)Regulatory: market access regulatory issues related to marketing authorizations for medicines, medical devices and health technology (software, programs, APPs) authorizations and other licenses related to manufacturing and distribution activities.
3) Advertising: design of promotional campaigns and activities for medicines, and health technologies, including the development of digital platforms and review of promotional materials for social media.
4) Commercial agreements: negotiation of sector-specific agreements (research and clinical trial contracts, co-development, CDMOs, licensing, distribution, manufacturing, co-marketing, etc.).
5) Tech & Data: drafting of impact assessments for complex healthcare technology projects, the validation of medical solutions and health technologies, providing support in the definition of AI management models.
6) Compliace: advising on compliance from a regulatory and criminal point of view, by drafting the necessary internal policies and procedures and implementing a whistleblowing channel.
7) Competition: reviewing of policies and procedures for drug distribution, pricing policies and discount setting, etc.
Gemma Colomer (gemma.colomer@fieldfisher.es) Principal Associate
Arian Gallardo (arian.gallardo@fieldfisher.es) Associate
Paseo de la Gracia 103, 7º
Barcelona - 08008
Barcelona
Tel: +34 934 150 088