Luz Helena Vargas

Practice Areas

Life Sciences & Healthcare

Career

- 2018-present – Associate Director, CMS Rodríguez-Azuero, Bogotá, Colombia

- 2010-2017– Partner, Mutter & Asociados S.A.S., Bogotá, Colombia

- 2007-2010 – Associate, Departamento de Registro Sanitarios, Cavelier Abogados, Bogotá, Colombia

- 2004-2007 – Legal Director, Naturcol LTDA., Bogotá, Colombia Colombia

- 2003-2004 – Intern, Departamento Administrativo de la Función Pública. DAFP – Proyectos especiales, Bogotá, Colombia

Professional Memberships

 Active member of the "Independent Regulatory Association" an association of companies and legal advisors that carry out practice and lobbying issues before INVIMA.

Personal

Luz Helena is an Associate Director for the Firm in the Sanitary Regulation team. She has over 14 years of experience advising national and foreign clients in matters of sanitary regulation in all procedures related to market approvals, and issues related to labelling, functional proclamations, and advertising approvals.

She leads the procedures and management of portfolios of health registrations at the national and international levels. She also has extensive experience in auditing processes (due diligences) for purposes of internal control and mergers and acquisitions of companies.

She has a vast experience in obtaining certification of facilities such as certification of Good Manufacturing Practices (GMP) of pharma products, renewal of Good Laboratory Practices (BPL) certification, production capacity of medical devices, storage capacity (CCAA), Certificate of technical production capacity or Certification of authorization, and approval of clinical studies protocols.

She also handles matters of Sanitary and Phytosanitary Regulation in the process of issuing sanitary licenses before the ICA in the sectors of animal husbandry and agricultural products and carrying out processes of Plant Breeder Rights.

Languages Spoken

Spanish