Our Life Sciences & Health Care team integrates Expert Technicians in Regulatory Affairs and Lawyers specialized in Sanitary Legislation that provide services to the productive sector: pharmaceuticals, medical devices, food, supplements, cosmetic products, hygiene and covers the needs in all regulatory issues for the operation of the establishments and the qualification of the products that the industry requires to place in the national and foreign markets and for imported products.

Given the constant updating of health regulations in the country, our advice ensures that companies in the pharmaceutical and consumer sector meet the requirements of the control authorities.

Our strategy is to keep our clients promptly informed of any changes that could affect their line of business. The experience that our team has allows us to foresee cases that could delay processes, adjust times and carry out the appropriate follow-up in each situation.

We act quickly in any circumstance to prevent the flow of information from stopping, due to the increasing regulatory requirements, we are always up to date. Our areas of action are detailed below:

• Regulatory strategy and classifications.
• Registration, Modification, Renewal of health records and health notifications.
• Preparation of the technical file.
• Preparation and review of labeling.
• Laboratory analysis evaluation.
• Review of certificates of conformity, labeling reports and INEN price test on imports.
• Technical representation services.
• Administration of registration certificates and health notification.
• Product renewal process schedules and operating permits.
• Review of promotion and advertising.
• Request for Good Storage, Distribution and Transport Practices (BPADT) based on the contract with the logistics operator.
• Updates due to changes in regulations.
• Presentation of PSUR, Pharmacovigilance.
• Solve regulatory requirements and queries.
• Support of interactions with the regulatory agency.
• Sanitary defense in the management of administrative processes by subsequent control.
• Product stock depletion request.
• Advice on recall processes.
• Report of drugs and substances subject to control

Recognition

Dentons achieves 157 rankings in Chambers Latin America 2025

August 23, 2024

Independent legal publisher Chambers and Partners continues to recognize Dentons lawyers as market leaders throughout Latin America and the Caribbean.

Insights

New Andean Technical Regulation for the Labeling of Cosmetic Products

March 7, 2023

Ecuador: This document presents a summary of the most relevant aspects of Resolution No. 2310 of the General Secretariat of the Andean Community, published in the Official Gazette of the Cartagena Agreement No. 5095 of December 16, 2022. The Resolution includes the labeling requirements that cosmetic products must comply, if marketed in the countries of the Andean Community (Bolivia, Colombia, Ecuador and Peru).

News and Events

Recent Press Releases

Dentons achieves 157 rankings in Chambers Latin America 2025

August 23, 2024

Independent legal publisher Chambers and Partners continues to recognize Dentons lawyers as market leaders throughout Latin America and the Caribbean.