ATT. MELISSA GARCIA
Deputy Chief Regulatory Department
BIOGRAPHY
Melissa García Mera is Deputy Head of the Regulatory and Healthcare Law Department at Meythaler & Zambrano Abogados. She advises pharmaceutical, food, and agribusiness companies on the legal requirements governing their facilities, products, and operations.
Her practice covers product registrations, good storage, distribution, and transportation practices, drug and medical device safety monitoring, advertising, and pharmaceutical pricing. She also handles pharmaceutical test data protection matters and represents companies in administrative enforcement proceedings.
She combines legal analysis with the coordination of technical regulatory matters to help clients identify risks and respond to health authorities’ requirements. Her previous experience in corporate and tax law complements her understanding of clients’ business needs.
PRACTICE AREAS
Regulatory and healthcare law.
Life sciences.
Pharmaceutical, food, and agribusiness regulation.
Administrative enforcement proceedings.
Pharmaceutical test data protection.
Regulatory compliance and risk management.
EXPERIENCE
MEYTHALER & ZAMBRANO LAWYERS.
Deputy Head of the Regulatory Department
(August 2021 – Present).
MEYTHALER & ZAMBRANO LAWYERS.
Legal assistant
In charge of the Tax and Corporate departments.
(October 2020 – August 2021)
COMPREHENSIVE CENTER FOR LEGAL ADVICE OF THE UNIVERSITY OF THE AMERICAS
Pre-professional Internships
Legal advice, sponsorships and monitoring of causes for people in a state of vulnerability.
(2019)
NATIONAL DIRECTORATE OF PUBLIC DATA REGISTRATION AND THE UNIVERSITY OF THE AMERICAS
Campaign ¨My data is me¨
(2019)
EDUCATION
Postgraduate Specialization in Administrative Law
Universidad Andina Simón Bolívar
2025–2026.
Law Degree
Universidad de las Américas
2015–2020.
CERTIFICATIONS
Pharmacovigilance in Pharmaceutical Establishments: Resolution ARCSA-DE-2025-052-DASP
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria (ARCSA)
August 2026.
Comprehensive Pharmacovigilance Management Program
Asepharma, with support from Ecuador’s Ministry of Public Health
2025.
BioFusión Ibero-American Conference on Biotechnology, Health, and Innovation
Faculty of Law, Universidad Nacional Autónoma de México
2025.
Medical Device Safety Monitoring and Regulatory Affairs Update for Healthcare Facilities, Pharmaceutical Establishments, and Medical Device Companies
ARCSA
2024.
National Workshop on Implementing the Rotterdam Convention in Ecuador
Food and Agriculture Organization of the United Nations (FAO)
2023.
Contract Law: From Trust to Promise to Contract
HarvardX
2020.
Seminars on Public Procurement and Intellectual Property
Instituto Iberoamericano de Leyes y Economía, Universidad de Cuenca, and COBRANSUR
2020.
Seminar on Economic, Employment, and Tax Law
Universidad de Cuenca and LATIN IURIS
2020.
LANGUAGES
Spanish and English