Pharmaceutical and Healthcare Law

The Pharmaceutical and Regulatory Law practice provides legal advice to pharmaceutical laboratories, pharmacies and pharmacy chains, distributors, importers, and other stakeholders in the healthcare industry on health regulations and regulatory compliance in Ecuador. The practice covers assistance with health registrations and permits, authorizations, licenses, and certifications, as well as proceedings before ARCSA and other competent authorities, including inspections, administrative proceedings, sanctions, and appeals. We also provide specialized advice on the commercialization, storage, distribution, and dispensing of medicines and products subject to health controls, advertising and promotion of pharmaceutical products, labeling, pharmacovigilance, compliance with good practices, contracting and structuring of regulated operations, as well as the identification, prevention, and management of regulatory and health risks.