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Regulatory Affairs
In Muñoz Abogados, we provide advice and dedicated representation in regulatory matters related to the health and safety of products. We focus on ensuring compliance with the sanitary regulations at national and international level, from obtaining health records to the defense in administrative processes sancionatorios. Our team provides accompaniment integral in the regulation of products, including foods, cosmetics, medications, and medical cannabis, among others.
Services in Regulatory Affairs
• Health records to INVIMA / ICA
• Certification of good manufacturing practices (gmp)
• Certificate of non-mandatory
• Registration of manufacturers and retail establishments to the INVIMA
• Import authorizations
• Concept of feasibility of use of a trademark on products subject to authorisation INVIMA
• Obtaining the CPC (Certificate of Compliance to Good Practices)
• Management of a portfolio of health records
• Audit of health records
• Review of advertising of regulated products
• Answers to objections, requirements and orders of the regulatory body (INVIMA)
• Concepts of the law on health care records
• Technical translation and legal (English, French, German and Spanish)
• Modifications, additions, changes and renewal of health records, disease notification mandatory or sanitary permit
• Legal representation in administrative procedures before regulatory bodies
• Defense in administrative processes sancionatorios related to regulated products
• Accompanying on visits of inspection, surveillance and control
• Screening and counseling in GMP, GLP (Good Laboratory Practices), AUTONOMOUS communities (Quality Assurance)
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