- 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 the distribution of products throughout Latin America.
- Identify and implement the 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 the 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.
