Carla Calderón

Carla regularly advises on matters in the intersection of regulatory, data privacy and intellectual property for the manufacturing, import, distribution, advertising, labeling, commercialization and post-market vigilance of medicines, medical devices, food and beverages, cosmetics, seeds, cannabis, veterinary products, chemicals, alcohol and tobacco.

She has experience in consultancy, government relations, administrative proceedings, healthcare litigation, registration of products, as well as contractual work.

• Designing and executing a strategy for a German pharmaceutical company in relation to the pre-submission regulatory meeting with the New Molecules Committee. 
• Advising an Italian chocolate company on issues relating to the use and labelling of food additives, including a government relationship strategy to obtain ruling requests from the Sanitary Authority. 
• Advising a US pharmaceutical company to implement the linkage system between patents and health authorizations in Mexico.
• Advising a US herbal products company to register products in Mexico, including dietary supplements, herbal remedies and herbal drugs.
• Advising a US pharmaceutical company on several contractual and regulatory issues relating to clinical trials.
• Litigating for several pharmaceutical and medical devices companies the approval of market authorization modifications, market authorization extensions, import permits and new market authorizations.
• Advising several pharmaceutical companies on the new regulatory framework for biotechnological drugs and biosimilars in Mexico.
• Advising several pharmaceutical companies on how to navigate the changing regulation of orphan drugs in Mexico.
• Advising a US based genetic test company on the regulatory issues, and how to address them, to market cross-border genetic tests in Mexico.
• Advising a French pharmaceutical company on how to navigate the industrial use of human tissue in Mexico.
• Securing several healthcare authorizations from the Sanitary Authority for the personal use of Cannabis.

• Health and Health Regulation Committee of the National Association of Company Attorneys (ANADE) for the biennium 2023-2024 - Coordinator
• Association for Health Law and Regulation (AMDERSA) - Founding Member, Executive Secretary