Your regulatory gateway to Guatemala
Streamline your market entry with expert Regulatory Affairs services. We handle the bureaucracy so you can focus on business expansion.
YOUR SUCCESS IS OUR COMMITMENT
We are experts in the pharmaceutical and food industries. Our mission is to provide solutions that simplify regulatory hurdles, saving you time and ensuring your products reach the market without delay.
We manage the entire technical process so you can focus fully on your business expansion and sales strategy.
About us
REFAR is a specialized regulatory consulting firm based in Guatemala City. We act as the technical bridge between international manufacturers and local health authorities (MSPAS). We ensure strict compliance with complex regulations, allowing you to launch your products successfully and without delays.
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Certified Technical Expertise
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English-Speaking Support
Frequently Asked Questions
What services does REFAR offer?
We manage the full lifecycle of sanitary registrations and establishment licenses in Guatemala, from dossier compilation to final approval by the Ministry of Health (MSPAS).
Which product categories do you handle?
Pharmaceutical products.
Biologicals and Biotechnological products.
Natural medicinal and Homeopathic products.
Food and Dietary Supplements.
Cosmetics and Hygienic products.
Medical Devices, Dental products, and Diagnostic Reagents.
Pesticides.
How long does it take to obtain an Establishment License?
Depending on the type of facility (e.g., Distributor, Drugstore), the process typically takes 2 to 3 months.
What are the estimated approval times for Product Registrations?
Timelines vary by category:
Cosmetics & Hygienic Products: 6 – 8 months.
Pesticides & Medical Devices: 6 – 8 months.
Pharmaceuticals, Biologicals & Supplements: 12 – 18 months.
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