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Luz Helena Vargas

Luz Helena Vargas

Associate Director

CMS Rodríguez-Azuero
Calle 75 No.​ 3-53
Languages Spanish

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.

Professional Experience

  • 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
  • 2003-2004 – Intern, Departamento Administrativo de la Función Pública. DAFP – Proyectos especiales, Bogotá, Colombia
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  • 2016 – Specialization in Corporate Law, Universidad Colegio Mayor de Nuestra Señora del Rosario, Bogotá, Colombia
  • 2004 – Lawyer, Universidad Autónoma de Colombia, Bogotá, Colombia
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  • Active member of the "Independent Regulatory Association" an association of companies and legal advisors that carry out practice and lobbying issues before INVIMA.
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27 April 2020
Pro­ced­ures of San­it­ary Reg­u­la­tion for “Non-In­dis­pens­able” Products in times...
"Com­ments on the Health reg­u­la­tions situ­ation for products that are not used for crisis man­age­ment"
20 April 2020
CMS Ex­pert Guide to ad­vert­ising of medi­cines and med­ic­al devices
Are you look­ing for in­form­a­tion on phar­ma­ceut­ic­al ad­vert­ising reg­u­la­tion and med­ic­al device ad­vert­ising? Learn more about it in this CMS Ex­pert Guide.
13 April 2020
Colom­bi­a's Health Au­thor­ity ad­apts to COV­ID Health Emer­gency: On­line pro­ced­ures,...
20 April 2020
CMS Ex­pert Guide to can­nabis law and le­gis­la­tion
Are you look­ing for in­form­a­tion on can­nabis law and le­gis­la­tion? This CMS Ex­pert Guide provides you with everything you need to know.
08 July 2019
Policy of Pre­ven­tion of Anti-Ju­di­cial Dam­age and De­fense Of IN­VIMA In­terests