Life Sciences
Brazil Guide 2024 : Brazil
Band 1
Email address
[email protected]Contact number
+55 11 3149 6100About
Provided by Kestener & Vieira Advogados
KVLAW’s Life Sciences team has experience in complex business negotiations, consultation, and litigation matters in both the administrative and judicial spheres involving market placement of regulated products with an emphasis on the following:
- Regulatory issues: consulting and administrative litigation related to Health Authorities at various levels of government (Ministry of Health, ANVISA, State and Municipal Health Secretariats, etc.);
- Writs of Mandamus and other legal actions disputing government acts, including, but not limited to, local and international inspections for Good Manufacturing Practices Certifications (CBPF), Federal Operating Permits (AFE); local Operating Licenses (LF) and Import Licenses (LI);
- Consulting related to the installation of industries in Brazil with special emphasis on obtaining, amending, canceling and transferring product registrations and assistance during the corresponding administrative proceedings;
- Consulting on administrative matters involving organizations such as INMETRO and IPEMs, advising on the corresponding administrative defenses;
- Development of industry-specific Compliance Programs (relationship with government agencies, public and private sector physicians, and public and private sector health service providers);
- Clinical Research and its developments before the CEP/CONEP system;
- Productive Development Partnerships (PDPs) involving technology transfer agreements, in line with the National Medicines Plan.
Chambers Review
Life sciences powerhouse Kestener & Vieira Advogados provides top-of-the-market regulatory assistance to heavyweights from the pharmaceutical, food and healthcare industries. The team is also highly experienced in handling both administrative and judicial cases relating to an array of matters, including product liability and class actions. São Paulo-based Kestener & Vieira also stands out for representing clients in high-end contractual negotiations and corporate deals connected to the sector.
Work Highlights
- Kestener & Vieira assisted Adium with several legal aspects of the negotiation and deal that the Adium Group entered into with Moderna in order to distribute the vaccine for COVID-19 in Brazil and Latin America, including assistance with compliance with corporate, licensing and regulatory requirements.
Strengths
Provided by Chambers
"Kestener & Vieira Advogados responds to sophisticated matters in a clear and agile way."
"Kestener & Vieira shows respect and attention to all internal demands, regardless of value, complexity and/or impact. Such behaviour makes us feel comfortable contacting them in every situation."
"Extremely fast responsiveness, from matter intake to final product delivery. Whenever additional issues arise - and they never fail to arise - they are able to help us navigate and prioritise."
"Kestener & Vieira Advogados responds to sophisticated matters in a clear and agile way."
"Kestener & Vieira shows respect and attention to all internal demands, regardless of value, complexity and/or impact. Such behaviour makes us feel comfortable contacting them in every situation."
"Extremely fast responsiveness, from matter intake to final product delivery. Whenever additional issues arise - and they never fail to arise - they are able to help us navigate and prioritise."
Notable Practitioners
Beatriz Kestener is a prestigious life sciences practitioner who has skills in matters such as complex regulatory cases. She also advises on cases before ANVISA.
"Beatriz Kestener handles complex matters and shows great knowledge about life sciences issues."
"The principal attorney in Brazil on life sciences matters. Beatriz Kestner is an authority on this topic."
Joining the rankings this year, Fabio Alonso Vieira is skilled in advising important clients on contentious matters in the life sciences arena.
Fabio Alonso Vieira is skilled in advising important clients on contentious matters in the life science arena.
"Fabio Alonso Vieira is open-minded and finds creative solutions. He is close to and aligned with his team."
"He is very pragmatic and has strong knowledge."
Flávio Augusto Spegiorin Ramos joins the rankings this year as an up-and-coming practitioner after impressing peers and clients alike. Flávio boasts expertise advising clients from the pharmaceutical, food, agricultural, cosmetic, medical device, retail and technology sectors on life sciences-related matters.
"Flávio Augusto Spegiorin Ramos prioritises our matters, answers us promptly, and is always willing to help."
Ranked Lawyers at
Kestener & Vieira Advogados
Brazil
Members
Provided by Kestener & Vieira Advogados
Head of Department
Flávio Augusto Spegiorin Ramos
Guilherme Gieron Fonseca e Silva
Henderson Fürst
Industries
Provided by Kestener & Vieira Advogados
Pharmaceutical, medical, drugs, biotechnology products, food, beverages, health services, and crop farming, including pesticides and fertilizers.