The Life Sciences Industry Group’s mission is clear – OLIVARES is changing and facilitating the regulatory landscape for companies doing business in Mexico. The firm represents many of the world’s leading innovators involved in research, development, and manufacture of pharmaceuticals, biotech products, agricultural goods, chemicals, medical devices, as well as food and beverages.
OLIVARES advises on a variety of regulatory issues for R&D Life Sciences clients and is widely considered the top influencer in changing the regulatory landscape in Mexico in pharmaceuticals. The firm has been the driving force setting new precedents in the following areas:
The legal framework of health authorizations and approvals
Sanitary, marketing authorizations and approvals advice, legal analysis, and actions when processes are not observed by the regulatory agencies.
Regulatory Data Exclusivity: Earned recognition of Regulatory Data Exclusivity for R&D pharma companies in Mexico in line with international trade agreements and treaties.
Pharmaceutical pipeline pharmaceutical patent term corrections based on a transitory article of the derogated IP Law.
Patent Linkage: Shape the criteria for the inclusion of formulation and use patents in the linkage gazette. No other firm in Mexico has had more influence on the patent linkage system.
First actions to obtain authorizations for the medical use of cannabis pre-the new law and regulation for products containing cannabis.
Taking a lead role in the CPTPP and USMCA negotiations on behalf of the R&D pharma associations doing business in Mexico
Filing amicus briefs on biologic drug regulations
Created a proprietary database system of the Mexican Trademark Office and the regulatory agency COFEPRIS that predicts whether a drug will gain the authorization of the commercial name by COFEPRIS.
Enforcement of exclusive rights in public acquisitions for pharmaceuticals, including before UNOPS.
Preparation and drafting of agreements in the life science sector.
Transfer of marketing authorizations and assets in the life science sector.
Labeling requirements for clearance of regulated products.
Administrative Compliance. The pharmaceutical, biotechnology, clinical laboratories and medical device sectors must always be prepared to respond to the emergence of actions and reviews as a part of regulatory compliance. In many cases, non-compliance carries serious consequences that include fines, along with civil and criminal penalties.
OLIVARES helps clients assess business practices and proactively monitor compliance programs in matters related to privacy, antitrust, anti-corruption and other related laws. The Firm is called upon from time to time to conduct corporate investigations that serve as tools for managing risks of non-compliance or alleged non-compliance behaviors. This can be valuable in all phases of the cycle of compliance within the legal framework in Mexico, from supporting the development of a robust compliance program, to further investigations, training, and remediation of illegal behavior or non-compliance.
Transactional. Another facet of comprehensive services for this industry includes transactional support for the various operations of clients involved in the development, consolidation, and expansion of their respective businesses in Mexico. The group of experts in transactional matters helps foreign clients to structure their businesses in Mexico and to carry out various inherent transactions. OLIVARES frequently participates in the advisory and strategy of mergers and acquisitions and sale of assets, which often includes intellectual property portfolios, authorizations and sanitary records, databases, inventories, licensing, joint marketing agreements, distribution, supply, and marketing, where the firm maintains sight of all the relevant elements of these sophisticated transactions: intellectual property, regulatory issues, economic competition, and other issues related to the legal framework in Mexico.
OLIVARES has built solid experience in advising and providing corporate structures for companies in the life sciences sector, based on extensive knowledge of the industry and the market.