High Performance

PRACTICE AREAS

Regulatory
REGULATORY The procedures for legalization and registration of companies and products regulated by the National Health Surveillance Agency – ANVISA, Ministry of Agriculture and Environment can consume valuable time and resources due to the complexity of national legislation and the respective special rules in force. Therefore, we understand that prevention is the best way to avoid significant losses in projects of this nature. Strategically outlining each move through the interpretation of the laws that orbit the regulatory landscape, as well as the special regulations of each government agency is critical to the success of these projects. Recognizing this need, we have prepared a team of specialized lawyers coordinated by founding partner Dr. Pedro Cassab to:

Legal guidance for authorization, licensing and regularization of companies and products;

Legal Orientation on inspection and control actions in Federal, State and Municipal spheres;

Legal guidance on corporate actions to adapt and transfer sites and establishments, involving issues of legalization and regularization in the Federal, State and Municipal spheres;

Legal guidance for the transfer of ownership of registrations and licenses at ANVISA involving large corporate operations (merger, acquisition, merger & spin-off) at Federal, State and Municipal levels;

Legal advice and support in negotiations;

Development, review and adaptation of contracts and documents involving commercial operations for the formalization of commercial partnerships; supply; distribution; representation; transportation and storage in accordance with the sanitary rules of the Federal, State and Municipal spheres;

Advisory support on strategic matters for decision making;

Legal support for bidding processes involving directly analysis and review of documents for accreditation, qualification, formalization, and execution of a public contract, as well as elaboration of challenges, defenses, and administrative appeals;

Guidance and legal support on acts and actions of inspection and control over imports in Ports, Airports and Borders that may directly impact the free exercise of economic activity through the elaboration of documents, challenges, defenses, and administrative appeals;

Guidance and legal support on acts and actions of control and inspection of Registries and Certifications that may directly impact the free exercise of economic activity through the elaboration of defenses, challenges, and administrative appeals;

Legal guidance on international norms of sanitary law of direct impact in the exercise of economic activity;

Legal advice on joint actions among entities of the Union, States and Municipalities involving the National Health Surveillance Agency (ANVISA), Ministry of Agriculture (MAPA) and Environment, Federal Revenue Secretariat (SRF), Administrative Council for Economic Defense (CADE) and other government agencies for the purpose of control and investigation with direct impact on the company’s economic activities;

Support for qualification of local and foreign suppliers;

Orientation and counseling for challenges, defenses and administrative proceedings involving Administrative Infringements of the Federal, State and Municipal spheres;

Guidance on enforcement actions in Techno-surveillance and Pharmacovigilance;

Support for analysis, review, and preparation of documents;

Advice to elaborate answers for letters and notifications;

Support in the interpretation of special norms through the elaboration of Technical Opinions;

Support for Risk Management;

Due diligence.

São Paulo

Avenida Dr. Chucri Zaidan . 296

23º andar - Cjto. 231 . Torre Z

Vila Cordeiro - CEP 04583-110

T/Phone + 55 (11) 3376-6343