PRACTICES
Life Sciences & Healthcare
Cecilia Alarcón is a pharmaceutical chemist. She specializes in health regulation and practices this discipline without providing legal advice.
With more than 10 years of experience, she advises on health regulation of pharmaceuticals, medical devices and medical products (cosmetics, personal and household hygiene products, disinfectants), pesticides for domestic use and public health. She also advises on compliance and certification in good practices and quality management for pharmaceutical establishments, pharmacovigilance, health registration of food and beverages, cannabis for medical use, veterinary products and clinical trials.
Cecilia leads the technical area for obtaining authorizations, registrations and Mandatory Health Notifications for household hygiene products and disinfectants for domestic, industrial and public health use, as well as other health products. She also supervises the preparation and submission of dossiers for registration, re-registration and updates of registrations before the health authority.
She also has experience in managing audits of warehouses and laboratories of health products, ensuring compliance with Good Manufacturing, Storage, Distribution and Transport Practices. She provides support in correcting technical observations, such as stability studies, certificates of analysis, technical reports, safety data sheets, among others, issued by the health authorities and in control and surveillance procedures initiated by the competent authorities.
Cecilia participates in the development of technical-legal strategies for the entry of new products, in order to obtain the necessary authorizations and regulatory protection, coordinating with the regulatory and quality areas of the parent companies of the clients in the region, as well as in the United States and Europe.
Previously, she worked as technical director of pharmaceutical offices and drugstores of national and imported health products, pharmaceuticals and medical devices, and in the technovigilance of international laboratories with presence in Peru.
Universidad Nacional Mayor de San Marcos – Pharmaceutical Chemists (1994)
Universidad Peruana Cayetano Heredia – Diploma Course in Intellectual Property and Pharmaceutical Law (2011)
Universidad Peruana Cayetano Heredia – Master’s Degree in Intellectual Property and Pharmaceutical Law (2017)
Austral University – Intellectual Property Internship, Life Sciences and Pharmaceutical sector (2017)
Universidad Peruana Cayetano Heredia – Master’s Degree in Pharmaceutical and Intellectual Property Law (2024)
Regulatory Affairs Proffesionals Society (RAPS)
International Society of Pharmacovigilance (ISOP)
Peruvian Pharmacovigilance Society
Peruvian Pharmaceutical Chemists Association
Spanish
English