Practice Silva de Moraes
Providing legal advice for a wide range of regulatory matters including: Marketing Authorization Approval; Fraud and Abuse, Marketing, Avertising, Promotion, labelling and other FDA regulatory including clinical R & D issues, impact of proposed legislation and reporting requirements and other regulatory matters.
Drafting and Negotiating pharmaceutical or medical device related commercial contracts (e.g. supply, manufacturing, distribution, managed care).
Interfacing with clinical research organizations to facilitate clinical trials.
Providing legal advice for a wide range of regulatory matters, including but not limited to product promotional activities and product pricing, guidance and practical solutions.
MEDICAL DEVICE, COSMETIC
SILVA DE MORAES has considerable experience in providing legal advice and assistance on the cosmetic and medical device field. The firm represents major cosmetic and medical product manufacturing, distributor and retailer clients all over the world providing services in matters relating to the development, manufacture and marketing of products regulate by the Brazilian Agency (and also other related agencies in Latin America countries) and the European Commission. This cutting-edge regulatory practice handles everything from product formulation and marketing authorizations issues to postmarking compliance, lifecycle management and significant enforcement matters.
Silva de Moraes develop personal opinion in Food and Drug Law for pharmaceutical, food, cosmetic and medical devices companies marketing in Europe, Brazil - Mercosur informing them about the state of the law and give them an opinion on how realistic their expectations are.
The Legal Opinion helps companies to navigate in different regulatory landscape.
Recognized for its performance in the food law, Silva de Moraes has the knowledge and experience necessary that give the food companies the edge they need to succeed in the region. The Office has a comprehensive and extensive food practice (25 years) promoting, protecting and defending food products (beverage, food, dietary supplements, additives , etc). Silva de Moraes represent clients in addressing all issues related to these products, including the suitability of their composition, inspection of manufacturings facilities and restaurants.