Andrés Enrique Hidalgo Andrade is a lawyer, specialist in intellectual property and commercial law. Andrés has more than 13 years of experience working on pharmaceuticals, healthcare, sanitary and regulatory affairs. Andrés also has experience in intellectual property matters.
Before joining Baker McKenzie, Andrés worked for Aristizábal & Jiménez as Senior Lawyer, then Andrés worked for Quala S.A. as Senior Regulatory Affairs Advisor; also, Andrés worked for the Colombian National Health Institute as Intellectual Property and Data Protection Advisor.
Andrés has experience advising national and multinational companies on pharmaceuticals, healthcare, sanitary regulatory affairs and intellectual property matters, by planning and supporting different strategies to allow the commercialization, marketing and advertising of different products such as medicines, medical devices, diagnosis tests, dietary supplements, foods, alcoholic beverages, cosmetics, pesticides, and others.
Andrés handles health registration prosecution and modifications, marketing approvals, certifications and authorizations for production, good manufacturing practices and clinical trials, advertising and labelling valuations, and others necessary health and regulatory procedures before national and local authorities, including representations during administrative, sanctioning and judicial process before official and judicial authorities.
Representative Legal Matters
- Advised pharmaceuticals companies on the importation process of Vital Unavailable Medicines to Colombia.
- Advised pharmaceuticals companies on the process of supplying drugs, medicals devices and diagnosis test, trough expanded access programs, according to Colombian regulation.
- Advised pharmaceuticals companies on the importation process of Vital Unavailable Medicines to Colombia avoiding the risk of losing undisclosed data protection.
- Advised pharmaceuticals companies on the process of registration of value transactions to healthcare service providers and other related professionals and companies.
- Advised pharmaceuticals companies on different procedures of medical devices registration before Invima.
- Advised national and foreign companies on different procedures of foods registration before Invima.
- Advised national and foreign companies on different procedures of cosmetics registration before Invima.
- Colombia (2011)
- Del Rosario University (Specialist in Commercial Law) (2012)
- Del Rosario University (Specialist in Intellectual Property Law) (2011)
- Universidad Militar Nueva Granada (Lawyer) (2011)