The area of Regulatory Law in Life Sciences & Agribusiness plays an essential role in balancing scientific innovation and the protection of public interests. In Brazil, a country recognized for its vast biodiversity and potential for scientific research, regulation in this field is crucial to ensure responsible access to genetic resources and to address emerging issues such as cannabis regulation.
Daniel Law offers a variety of services to assist companies, research institutions and other stakeholders in complying with specific regulations related to products and activities in the areas of health, biotechnology, seeds, pesticides, pharmaceuticals, food, cosmetics, medical devices and other aspects of the sector.
Expertise and advocacy: we offer guidance in understanding different sectors of the Life Sciences industry, including Agribusiness, interpretation of normative acts and in the elaboration of regulatory standards, including support in the context of public consultations and legislative discussions.
We act in the resolution of administrative and judicial disputes, linked to regulatory authorities at all levels of government (Ministry of Health, ANVISA, CMED, Ministry of Agriculture, Livestock and Supply, State Secretariats of Agriculture and Health, Municipal Health Secretariats, among others);
Regulatory Litigation: In addition, we are prepared to represent our clients in disputes involving regulatory matters. This ranges from inspection procedures to administrative appeals and judicial proceedings, also including interventions in public civil actions and acting in strategic constitutional actions.
Strategic advice in relation to the implementation of manufacturing in the country, including obtaining, altering, cancelling and transferring of product registrations, as well as support in corresponding administrative defenses in the context of sanitary inspections and compliance with good manufacturing and quality practices;
Comprehensive advice on Clinical Research and its implications before the CEP/CONEP system;
Advising on contracts involving technology transfer, including issues related to the establishment of partnerships with the Brazilian government;
Issues related to Genetically Modified Organisms (GMOs);
Specialized advice on foreign investment in the country, covering the production and import of products, as well as mergers and acquisitions;
ACESS OUR INTERACTIVE TIMELINE TO SEE THE KEY REGULATORY HIGHLIGHTS FROM 2023
ACESS OUR INTERACTIVE TIMELINE TO SEE THE KEY REGULATORY HIGHLIGHTS FROM 2023
Broadening our scope
we also offer support in:
Access to Genetic Resources: Specialized guidance in navigating regulations regarding access to genetic resources. This includes assisting in registrations before SisGen, negotiating benefit-sharing agreements and ensuring full compliance with relevant legislation.
Cannabis Regulation: Our knowledge also covers the regulation of cannabis for medicinal purposes. We advise in obtaining the necessary authorizations, as well as in the development of products and compliance with the established rules.
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Labelling and Advertising: We provide detailed guidance on labelling, packaging and advertising requirements for regulated products. Our commitment is to ensure that all information is accurate, easy to understand and in full compliance with current regulations.
The regulatory area in Life Sciences & Agribusiness in Brazil is vital in promoting scientific innovation, while protecting the interests of biodiversity and society. Access to genetic resources and the regulation of cannabis are prominent themes, reflecting the ongoing search for balanced solutions that benefit both scientific advancement and public welfare. As science advances and the needs of society evolve, regulation in Life Sciences will continue to play a critical role in guiding and supporting responsible development.
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Some of the key
Broadening our scope
