Specialized regulatory consultancy with multidisciplinary support
The strong role of the National Health Surveillance Agency (ANVISA) in Brazil imposes several rules and specific procedures for companies operating or intending to operate in this sector, which must be in full accordance with the local standards. For these reasons, a specialized legal advice including a staff of attorneys with wide experience in this sector is vital for companies to exercise and to maintain their activities in compliance with regulatory rules. This necessity is even bigger for foreign companies, since the rules imposed by ANVISA may be quite different from those of their country of origin.
L.O. Baptista acts together with pharmaceutical companies, drug and medical device manufacturers, cosmetics, as well as importers and distributors of such products for over 15 years. In the recent years, it has worked for the startup of pharmaceutical laboratories and companies interested in operating in the sectors above mentioned.
A team fully dedicated to the area is responsible for analyzing rules and standards aiming the best advice for customers in taking decisions that involve the relationship with health surveillance agencies, as well as assisting the client in a multidisciplinary way, since our law firm provides legal advice concerning all the areas of law, such as mergers and acquisitions, tax, labor, contracts, among others.
The area as well as its professionals have been frequently highlighted by important national and international legal publications, such as Best Lawyers and Anuário Análise Advocacia.
How we can help:
• Incorporation of companies intending to work in segments regulated by ANVISA, requesting assistance on corporate and regulatory areas.
• Conducting due diligence of companies in the pharmaceutical sector.
• Analysis of specific rules related to the branch of activity of the company.
• Defense of companies in administrative proceedings opened by ANVISA.
• Monitoring of bidding procedures before the Ministry of Health (government procurement): document preparation, representation of the company at the opening session of the bid, appeals, and defense before the Court of Auditors.
• Defense in lawsuits involving medications.
• Follow up of Public Consultations opened by ANVISA.
• Consultations on Clinical Trial.
• Analysis of contracts.
