Cecilia Stahlhut Espinosa
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
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, research and development, digital health, biotechnology, compliance of new product technologies, and general health regulatory compliance. Cecilia has particular experience in the regulation of cosmetics, food, alcohol, tobacco, high tech and innovative devices, 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, post market safety, compliance with good manufacturing practices, 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 advised clients on promotional activities and compliance of regulations regarding interactions with health care professionals and related organizations, and implementation of patient programs.
Cecilia has seconded two major orphan drug companies to advise on regulatory framework applicable to orphan drugs as well as the ongoing business activities of the clients, including contracts, advertising, marketing, pharmacovigilance, and health-corporate governance.
Representative experience
Advising top multinational companies in the planning and adoption 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.
Credentials
- Law Degree, Universidad Anáhuac del Norte, 2009