Cecilia Stahlhut Espinosa
Cecilia Stahlhut Espinosa represents life sciences and consumer products companies in Mexico, with a focus on health and consumer law matters. She works with clients throughout all stages of complex and innovative projects. Her years of experience as external counsel to many life sciences companies offer her unique insight into the industry.
She has a wealth of experience in regulatory drug matters (pharmaceutical), medical devices and equipment, research and development, biotechnology, compliance of new product technologies, and general health regulatory compliance. Cecilia has particular experience in the regulation of cosmetics, food, alcohol, tobacco, and consumer products in Mexico.
She has also participated in the planning and adoption of regulatory strategies for various companies, with respect to product advertising and labeling, product liability, marketing of high-tech products, and the launching of new products. She also advises clients on sophisticated regulatory structures and the restructuring of business models and operations, clinical research projects, approval and marketing authorization pathways, standards for regulated products, and challenging labeling and advertising issues.
Cecilia has reviewed promotional materials for an extensive range of products and advised clients on promotional activities and compliance of regulations regarding interactions with healthcare professionals and related organizations.
Recently, Cecilia was seconded to a major orphan drug company to advise on regulatory framework applicable to orphan drugs as well as the ongoing business activities of the client, including contracts, advertising, marketing, pharmacovigilance, and health-corporate governance.
Areas of Focus
Advising top multinational companies in the planning of complex regulatory strategies in connection with business restructurings.
Advising companies on approval and marketing authorization pathways and standards for regulated products and compliance with labeling.
Reviewed advertising and promotion materials for an extensive range of products and advised clients on launching of innovative marketing campaigns.
Reviewed advertising and promotion materials for various products; served on promotional review committees; advised clients on promotional activities.