Healthcare And Lifesciences
KLA’s multidisciplinary Lifesciences team has in its client portfolio some of the largest national and multinational companies of the health sector. As a multidisciplinary practice, the group carries out works of various types, from specific regulatory issues to tax assessment, mergers and acquisitions, product registration and brand management, considering the peculiarities of the pharma and health products.
Experience
> Assessment on the development of internal compliance policies, focusing on the regulatory requirements of the pharma and health products sectors.
> Assistance on regulatory matters regarding the obtainment of operational permits with the National Health Surveillance Agency (ANVISA), local sanitary licenses and registration of products with the competence sanitary entities.
> Draft, review and advice for distribution agreements and outsourced production of sanitary regulated products.
> Representation of our clients before ANVISA, the Medication Market Regulation Chamber (CMED), the Ministry of Agriculture, Livestock and Supply (MAPA), the National Institute of Metrology, Quality and Technology (INMETRO), among other regulatory entities, on matters related to the registration of products, drugs and companies, discussions on price readjustments and administrative sanctioning procedures.
> Assistance with clinical trials in Brazil, including analysis and drafting of contracts and research protocols.
> Review of marketing campaigns and product labeling for the pharma and health products industries.
> Assistance in bidding procedures involving the acquisition of drugs, heath products and other regulated products.
> Assistance with the import and export of products subjected to the Sanitary Surveillance regime.
> Assistance in administrative and judicial litigation involving sanitary regulatory matters.
> Participation in meetings representing the Client’s interests before regulatory agencies, as well as consumer defense bodies and/or Public Prosecutor’s Offices.
