Rebexa supports pharmaceutical manufacturers and distributors looking to operate in Puerto Rico,a U.S. jurisdiction with its own complex regulatory requirements. We provide essential administrative and compliance services to help you operate legally and efficiently on the island.
Specialized Regulatory Support for Health-Focused Industries
Rebexa focuses exclusively on the industries where compliance is critical and delays can be costly. Our expertise spans medical devices, animal health, nutritional products, and pharmaceuticals, each with its own evolving regulatory demands. We don’t dabble. We specialize, so you get a partner who understands your product category inside and out.
Pharmaceuticals
Your Pipeline, Our Precision.
We help you:
• Navigate registration and licensing with Puerto Rico’s Department of Health, State, and Treasury
• Obtain Representative Agent certifications and Special Authorization licenses
• Manage controlled substance licensing and compliance
• Maintain accurate registration records and support changes to labeling, NDC, and distribution partners
Puerto Rico plays by its own rules. We know them inside and out.
Medical Devices
Where Innovation Meets Regulatory Precision.
Medical devices are one of Rebexa’s top areas of expertise. We support Class I, II, and III registrations across Latin America and the Caribbean with unmatched regulatory fluency and strategic insight.
From diagnostics and surgical instruments to software as a medical device, we guide your product through local classification systems, streamline submissions, and manage compliance every step of the way. Our speed, flexibility, and experience ensure your innovation gets to market,and stays there.
We handle:
• Device classification and registration strategy.
• Dossier preparation.
• Import license management.
• Post-market changes and renewals.
Veterinary Products
Born to Lead in Animal Health Compliance.
Rebexa was founded with a focus on veterinary regulation, and that origin still sets us apart. Our co-founder, Dr. Arnaldo Hernández, is a veterinarian by training, and our team has built an unrivaled track record supporting companies in this vertical. Whether you manufacture treatments for livestock, companion animals, or both, we offer the most specialized and reliable veterinary regulatory support in the region. No one does it better.
We provide:
• Country-specific registration support.
• Local representation.
• Labeling and packaging review.
• Renewal and variation filings.
Animal Feed & Nutrition
From Ingredients to Impact, We’ve Got You Covered.
Rebexa supports feed manufacturers and animal nutrition companies seeking market access across LATAM and the Caribbean, where technical and regulatory standards vary by market.
We assist with:
• Animal feed and pet food additive registrations.
• Renewal and Variation Filings.
• Product label compliance.
• Ongoing regulatory updates.
Personal Care
From Shelf to Self-Care, Fully Compliant
Rebexa supports personal care brands navigating complex, country-specific rules around cosmetics, supplements, and hygiene products. Whether topical or ingestible, we help you avoid delays and stay market-ready.
We handle:
• Product classification (cosmetic, supplement, OTC)
• Registration submissions and documentation
• INCI or CAS list and formula compliance
• Labeling, packaging, and marketing claims
• Forbidden substance verification
Environmental Health & Hygiene
Compliance Where Clean Matters Most
From disinfectants and sanitizers to pesticides and biocides, we help companies register and maintain environmental health products across Latin America and the Caribbean. These products often require coordination with multiple agencies, and we know how to manage them all.
We assist with:
• Product classification and registration strategy
• Dossier preparation and safety documentation
• Labeling and claims review
• Renewals, variations, and regulatory alerts
We register all of this in Puerto Rico.
Serving Industries That Can’t Afford to Wait
Let’s work together to bring your product to market, quickly, compliantly, and with confidence.
Contact Us
REGIONAL MARKETS
Please contact us by completing the form below and one of our team-members will reach out to you. We look forward to assistint you.