SERVICES
Health regulation
Our interdisciplinary team provides a comprehensive service in health regulation: from the importation or manufacturing of the product to its commercialization. We manage health registrations before INVIMA and ICA.
Products for Human Use (INVIMA)
- Application and management of health registrations: medicines, dietary supplements, medical devices, food, alcoholic beverages, cosmetics, and hygiene products
- Advice on the implementation of GMP, GHP, and GEP.
- Defense against administrative investigations for violation of health regulations.
- Comprehensive legal advice in life sciences.
- Product life cycle management: from trademark and patent registration to health registrations, labeling, and advertising.
Products for Animal Use (ICA)
- Application and management of health registrations before ICA.
- Diagnosis of the current status of regulatory processes before ICA.
- Preparation and organization of documentation for filing before ICA.
- Scientific advice on indications, contraindications, and precautions.
- Responses to health concepts and technical requirements from ICA.
Frequently Asked Questions
Authorizations from INVIMA certifying that a product meets safety, quality, and efficacy standards. Mandatory for medicines, cosmetics, processed foods, medical devices, and more.
Quality standards for facilities that manufacture, store, or distribute regulated products. Non-compliance may result in sanctions, closure, or cancellation of health registrations.
An SG-RS establishes monitoring, traceability, and document management protocols. It includes monitoring the validity of registrations, preparation for GMP audits, and regulatory updates.
