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Why Choose Rebexa?

Regional Expertise

Local presence in 16+ countries, with a team of regulatory specialists who know the terrain.

Healthcare Focus

Deep experience across medical devices, veterinary products, animal health, hygiene and personal care, and pharmaceuticals.

One Partner Every Market

We manage every detail from registration to post-market support, so you can scale without stress.

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Industries We Serve

The expertise you need. The focus you deserve. From medical devices to diagnostics, veterinary products and animal feed, our sector-specific experience ensures your compliance journey starts strong.

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What We Do

We handle it all, from strategy to representation. We take care of regulatory roadmaps, product submissions, and in-country hosting, so you can move faster, stay compliant, and focus on growth.

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Where We Work

Central America, South America, & the Caribbean. Covered. Puerto Rico, Colombia, Costa Rica, Dominican Republic, Ecuador, and more, each with its own rules. We help you get it right the first time.

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What Our Clients Say

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Confident Compliance Starts Here

Let Rebexa simplify your market expansion. We navigate the complexities. You drive the innovative breakthroughs.

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Rebexa FAQs

We provide in-country representation and regulatory affairs services across 15+ markets in Central America, South America, and the caribbean, including Costa Rica, El Salvador, Guatemala, Honduras, Panama, Nicaragua, Colombia, Ecuador, Venezuela, Peru, Puerto Rico, Dominican Republic, Jamaica, Trinidad & Tobago, Aruba, and Curacao.

Puerto Rico is a unique market: while it’s geographically in Latin America, it is a U.S. territory regulated by the FDA. This means that all pharmaceutical, medical devices, and other regulated products must comply with FDA standards. However, to commercialize these products locally, companies must also meet Puerto Rico-specific requirements, including permits, licenses, and special distributor authorizations.

Rebexa’s headquarters in Puerto Rico gives us deep knowledge of both federal and territorial systems. We streamline dual compliance processes and act as your local representative, ensuring that your product doesn’t just meet FDA requirements, but also meets everything needed to launch and scale successfully in Puerto Rico.

We serve the pharmaceutical, medical device, veterinary, animal feed, personal care, and environmental health & hygiene sectors, with deep expertise in registration and life-cycle compliance.

From orthopedic implants, IVDs, and vitamins, to vaccines, hospital hygiene products, and veterinary medicines, we’ve registered over 5,000 products across a diverse healthcare portfolio. Contact us to learn more.

Yes, in most markets we can represent your product legally via our own entity or trusted associates. Some countries require the importer to serve as the local representative, we’ll help clarify these details for your target markets.

We are your single point of contact across multiple countries, offering:

  • Over 30 years of experience

  • A team of 50+ experts

  • Local operations and relationships with health authorities

  • A holistic and agile approach to complex challenges

  • A proven track record of more than 93% client retention

Our 7-step process covers:

  1. Initial consultation

  2. Regulatory strategy development

  3. Documentation and dossier preparation

  4. Review and submission

  5. Approval and registration

  6. In-country registration hosting and representation

  7. Ongoing support, updates, and local representation

Absolutely. Our centralized project management model enables coordinated execution across countries, helping you accelerate time-to-market while maintaining quality and compliance.

Absolutely. Our centralized project management model enables coordinated execution across countries, helping you accelerate time-to-market while maintaining quality and compliance.

Yes. We don’t stop at approval. We provide:

  • Maintenance of registrations

  • Regulatory updates and renewals

  • Change management

  • Ongoing communication with MoH and distributors

Typically, we’ll ask for:

  • Product dossiers or CTDs (depending on market)

  • Certificates of Free Sale (CFS)

  • GMP certificates

  • Labeling and packaging files

  • Manufacturer and distributor details

We’ll guide you step-by-step through what’s needed for each country.

Yes. Whether you’re entering your first market or managing a large product portfolio, our services scale to meet your needs, with personalized attention and regional expertise.

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