Kestener & Vieira Advogados, Life Sciences

About

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

Provided by Chambers

Life Sciences - Brazil

Band 1

What the Team is Known For

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.

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Work Highlights

Provided by Kestener & Vieira Advogados

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 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.