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No One Knows Puerto Rico’s Regulatory Landscape Like Rebexa

Headquartered on the island, Rebexa offers end-to-end regulatory support for pharmaceutical, veterinary,  medical product, and environmental health & hygiene companies working within Puerto Rico’s unique and evolving requirements.

Puerto Rico Healthcare & Regulatory Consulting | Rebexa Group

Puerto Rico’s regulatory environment is unlike any other, operating under U.S. jurisdiction but with its own distinct processes, agencies, and administrative hurdles. Headquartered on the island, Rebexa understands every nuance.

We specialize in managing the administrative and compliance workload for pharmaceutical, veterinary, and medical product companies operating in Puerto Rico, so your internal teams can focus on growth, not paperwork. From registrations and licensing to renewals and representation, we handle the details that keep your business moving.

Why Clients Choose Rebexa

  • Based in Puerto Rico. Focused on Puerto Rico.   We’re not coordinating from afar. Our team lives regulatory day-to-day, enabling real-time problem-solving and local insights no remote partner can match.
  • Free Up Your Internal Team, Rebexa takes on your regulatory admin burden, so your staff can shift focus to revenue-generating roles like sales, marketing, and operations.
  • End-to-End Admin Support From controlled substances to labeling updates, we handle it all. No bottlenecks. No compliance risks.
  • Multi-Agency Coordination Made Easy, We manage filings and relationships across the Department of Health, Treasury, State, and Agriculture.
  • More Than Compliance. Strategic Alignment. We don’t just process forms. We align your regulatory approach with your commercial goals.
  • Bilingual and Culturally Fluent. Our team communicates seamlessly with both government agencies and client teams. No translation errors. No missteps.

Our Expertise

Licensing & Representation

  • Special Authorization Licenses (Rx, OTC, Veterinary, Medical Devices, Supplements, Environmental Health & Hygiene products)
  • Local Distributor Licenses
  • Representative Agent Certification
  • Controlled Substance Licensing

Registration & Maintenance

  • Registration for Prescription, OTC, Biologics, Controlled Substances, Veterinary, and Environmental Health & Hygiene products
  • Updates to Labeling, NDCs, Manufacturers, or Distributors
  • Registration Portfolio Database Management
  • Market Withdrawals and Variation Handling

Strategic Support

  • Regulatory Planning for Acquisitions and Portfolio Transfers
  • À la carte consulting services
  • Agricultural Product Registration (Pesticides & Disinfectants)

Let’s help you stay compliant, move faster, and refocus your team on what matters most.

Puerto Rico’s regulatory framework is layered and ever-evolving but managing it doesn’t have to slow you down. By outsourcing your regulatory admin to Rebexa, you can redirect internal bandwidth toward growth.

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Rebexa FAQs

  • Yes, they all require a registration.
  • No, they do not require registration. However, a Special Authorization for their distribution is required.
  • Yes, this is managed by a different division within the Department of Health and undergoes additional processes.
  • No, unless they are a combined medical device that includes an active ingredient. However, a Special Authorization for all medical device distribution is required.
  • Yes, these product categories fall within the Department of Agriculture jurisdiction. Only EPA approved products can be registered.

  • No, Puerto Rico falls under the jurisdiction of the United States, this means that only FDA/USDA approved products can be registered and distributed.

  • No, registrations do not expire. However, these registrations must be kept updated whenever their labelling, prescribing information, manufacturer, distributor or NDC number has changed.
  • It is the first step to distribute any of the following categories: Prescription, Over-the-Counter, Medical Devices, Veterinary Prescription, Non Prescription Veterinary, and Homeopathic, Natural or Nutritional Supplements.
  1. Obtain a Special Authorization License
  2. Obtain a Representative Agent Certification
  3. Register the Product

Yes, Rebexa Group can manage all the required steps to register your product!

Puerto Rico Doesn’t Play by the Same Rules. Good Thing We Know Them Inside and Out.

If you’re entering the market or need help maintaining compliance, Rebexa is your local, strategic advantage.

Let’s get your product to market, faster, safer, and with full confidence.

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