REQUEST A QUOTEProduct registrations and establishment licenses in Guatemala
We support the preparation, submission and follow-up of your regulatory applications, with technical guidance for your product or establishment.
Regulatory consulting in Guatemala
Regulatory support for products and establishments
At REFAR, we support Guatemalan and international companies in preparing and following up on regulatory applications. We assess each case according to the product, establishment and applicable requirements.
Establishment licenses
We prepare and follow up on license applications for establishments subject to health regulation, including renewals and amendments.
Product registrations
We review requirements and compile dossiers for food, medicines, cosmetics, medical devices and other regulated product categories.
Regulatory consulting
We assess documentation, labeling and requirements to define a clear compliance pathway before submitting an application.
A clear process from start to finish
We organize each application into stages so you understand the requirements, the status of your documentation and the next step.
1. Assessment
We identify the procedure and requirements that apply to your product or establishment.
2. Preparation
We review and organize the documentation before submitting the application.
3. Follow-up
We monitor the application and help address requests and observations from the authority.
Technical expertise for your project
Behind every regulatory application is a business project. At REFAR, we combine pharmaceutical expertise and experience in Guatemalan industry to provide advice that connects regulatory requirements with your company’s needs.
✓
Technical guidance tailored to each application
✓
Direct communication throughout the process
Latest articles (in Spanish)
Frequently asked questions
What services does REFAR offer?
We provide consulting and support for product registrations, establishment licenses and other regulatory procedures in Guatemala. We define the scope after reviewing each case and the available documentation.
Which product categories do you work with?
We work with medicines, biological and natural products, food, dietary supplements, cosmetics, hygiene products, medical devices, dental products, diagnostic reagents and pesticides, among other categories subject to health regulation.
How long does an establishment license take?
The timeline depends on the type of establishment, the documentation submitted, inspections or requests for additional information, and the authority’s processing times. After an initial assessment, we can provide an estimate for your case.
How long does product registration take?
Processing times vary according to the product category, country of origin, completeness of the dossier, requests for additional information and the authority’s workload. An initial assessment helps establish a more useful estimate for each application.
What information do you need to assess my case?
For an initial assessment, we need the type of product or establishment, country of origin, required procedure and available documents. This information allows us to outline the initial requirements and the next step.