Healthcare: Regulatory

About

Provided by Lefosse Advogados

Life Sciences & Healthcare practice is focused on a segment with high growth potential but we anticipate many regulatory challenges.

The sector is highly innovative which will produce a large volume of investment. However, this will entail important legal challenges, which can only be faced by professionals highly familiarized with the sector, as well as by the work of a multidisciplinary team who specialize in the most diverse fields of law such as regulatory, consumer, antitrust, contracts, intellectual property, criminal and so on.

Our services:

• Consultancy in administrative matters
• Litigation against acts of the Public Administration
• Advise on clinical research and its consequences
• Definition of drug pricing strategy before the CMED, preparation and review of DIP and appeals
• Due diligences
• Advise on PDPs
• Development and monitoring of Compliance Programs
• Litigation related to defective products or of inherent risk
• Issues related to consumer protection
• Assistance in bidding procedures
• Administrative contracts
• Negotiations with the Ministry of Health
• Advising on healthtechs
• Evaluation and structuring of projects that need to register before the ANS
• Negotiations with operators of health plans or insurance
• Consultancy and litigation involving the Ministry of Agriculture
• Structuring, launching and promotional campaigns involving products subject to ANVISA and MAPA
• Advising on issues related to agricultural products
• Advising on research and development involving GMOs