Our LSH department has a proven record in comprehensive legal advice to local, regional and international companies in this area, particularly in the following industries: health, animal health, chemistry, pharmaceutical, cosmetics & domisanitary, foodstuffs and beverages, biotechnology, medicine & telemedicine and cannabis industries.
The team in charge of this area holds a thorough knowledge in the industry’s national and local regulatory aspects, and works in coordination with the other teams at Guyer & Regules, particularly with the areas of data privacy, antitrust, consumer protection and administrative litigation. This enables to efficiently carry out any and all operations required by the clients.
We specialize in the following activities:
- Review of applicable legislation and legal and regulatory compliance audits
- Obtaining all kinds of authorizations, granted by applicable bodies for such purposes, particularly the Ministry of Public Health and the Ministry of Livestock, Agriculture and Fishery
- Legal advice related to proceedings before regulatory bodies and negotiations with control bodies
- Legal advice to clients in the registration and approval of pharmaceutical specialties, therapeutic devices and complex clinical studies. Registration transfers and allocation assignments
- Legal advice during the registration, proceeding and registration transfer of medical, veterinary, agrochemical, biological and bioequivalent products, as well as genetically modified organisms
- Joint venture, supply and distribution agreements and termination thereof
- Administrative actions against resolutions of regulatory bodies that are inconsistent with law and the clients’ interests
- Mergers and purchases of companies within the line of business
- Labeling of products, advertising practices and advice in antitrust-related issues
- Negotiation and drafting of licenses, distribution and logistics commercial agreements as well as manufacturing agreements