Life Sciences

About

Provided by Kestener Vieira Torronteguy Spegiorin Advogados

KVTS' 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.