Strong familiarity with all business aspects of medical device industry, providing legal and compliance oversight.
Advised on regulatory regime, registration, modification, extension and transfer of sanitary records of pharmaceutical products in most of Latin American region.
Drafting, negotiation and review of commercial agreements, including distribution, HCPs, placement, consignment, clinical studies and others.
Legal guidance to medical device manufacturers (life science, medical, industrial applications) in connection with distribution of products throughout Latin America.
Identify and implement most efficient legal alternatives for end-user product acquisitions and equipment distribution, while ensuring that compliance, regulatory and legal risks are identified, assessed and adequately addressed.
Expert counsel on anti-bribery, anti-money laundering, fraud, privacy, compliance with the FCPA and U.S. healthcare related statutes.
Involvement on implementation of Deferred Prosecution Agreement for largest distributor of endoscopes and medical equipment in the U.S. which paid $623.2 million to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals in the U.S. and Latin America.