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WHO WE ARE

Rebexa Group - Leading Healthcare Regulatory Affairs firm, providing management and consulting services for pharmacuticals, medical devices, and veterinary clients.

Founded in 2006 by Dr. Arnaldo Hernández and Naiomi Chardón to assist medical companies in complying with product registration in Central America and Caribbean countries, Rebexa Group has become the leading consulting firm for outsourced regulatory affairs services in Latin America.

  • Mr. Hernández worked for 13 years in the technical services and regulatory compliance area of a well-known pharmaceutical company.
  • Mrs. Naiomi Chardon also spent over a decade occupying various positions of increased responsibility in a leading pharmaceutical company, reaching Regional Marketing Director prior to founding Rebexa Group.

Aware of the in-house necessity of more focused and experienced regulatory personnel, they entered and won a renowned business plan competition.

As a result, Rebexa Group eventually became the first regional company to merge the core regulatory affairs activities of current in-house resources and local regulatory affairs services, providing a one-stop shop for clients within the pharmaceutical, medical devices, and veterinary industries.

Expertise

Our expertise comes from many years of working solely with healthcare companies. We comprise aa team that combines more than 30 years of experience in medical, pharmaceutical, medical devices, and veterinary matters.

Rebexa Group is the first regional company to merge the core regulatory affairs activities and services for different countries in the Caribbean, Central America, and Andean regions, providing a one-stop-shop for a great number of leading healthcare companies.

Location

Headquartered in Puerto Rico and with offices and/or personnel in over 16 Latin American and Caribbean countries.

Rebexa Group offers flexibility and support that every client needs. In this field and region, we are the firm with the knowledge and experience of working directly with local regulatory agencies and health authorities on behalf of clients within the healthcare industry.

Learn how Rebexa Group can be your partner and representative for regulatory affairs services in Central America, the Andean Region, and the Caribbean.

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Why Rebexa

Rebexa Group helps you improve control over your company’s product registration and regulatory affairs responsibilities in Central America, the Andean Region, and the Caribbean markets.

Rebexa Group is headquartered in Puerto Rico, a strategic location between the North American and South American markets and one of the world’s premier manufacturing sites for medical products.

This location provides convenient access to a broad range of resources within the pharmaceutical, therapeutic, medical devices, and veterinary industries, all within the auspices of the well-known legal framework and accountability of a United States territory.

With offices and/or personnel in over 16 Latin American and Caribbean countries, we have executed a wide array of regulatory intelligence projects, from developing regulatory manuals per country to providing regulatory insight information related to Due Diligence, Post-Merger Implementation, Change of Manufacturer, and more.

As a result, direct communication has been established with manufacturers, suppliers, and distributors to ensure a sustainable customer relationship.

Currently, we manage a portfolio of over 2,500 registrations in therapeutic areas such as medical devices and human and veterinary pharmaceuticals.

Our goal is to achieve complete customer satisfaction in all the services we offer. Rebexa Group’s performance will be in accordance with the highest standards of ethics, compliance, and confidentiality, abiding with the Foreign Corruption Practices Act.

Our personnel are continuously trained on our internal Quality System and regional legal framework to ensure utmost efficiency, transparency and legality.

OUR PURPOSE

“We enable essential and life saving products, to reach consumers as fast as possible”

OUR VALUES

Our values shape everything we do as a company, from what happens in the lunch room to how we work with our clients. These are the five qualities that you’ll find expressed throughout every part of our business.

OUR CULTURE

We act as a team in a manner which earns the trust of others by encouraging continuous transparent  communication; constantly seeking opportunities to grow and learn professionally, providing the highest quality of services, while putting customers first to reach our companies’ common goals.

  • Acting with Integrity

    We behave in a manner that demonstrates trust, honesty, courage, consistency and responsibility with a willingness to admit our mistakes and taking ownership of everything we do. Specifically, this means transparent communication, We are always available to answer questions and provide any information about our process that might be helpful to clients.

  • Obsessed about quality

    Quality for us means maintaining rigorous standards for all of our work, no matter how big or small the project. We care deeply about our work, the future of our employees, about providing excellent customer service, and we truly care about achieving results for our clients.

  • Fostering Teamwork to ensure combined experience and expertise

    The strength of our team does not only lie in our combined experience and expertise but our ability to trust each other, no matter what the circumstances. We know that our best work is not produced by individuals but by enjoying collaboration as a team and supporting each other every day. This team mentality also extends to our clients as we approach every business relationship as a partnership and work collaboratively with each other to meet our goals.

  • Committed to Performance

    Excellence lies at the point where our intentions and their impact are closely aligned, and we are able to achieve this over and over again.

  • Timeliness makes it easier for us to work together

    We ensure the time between when information is expected and when it is readily available for use, complies with all parties expectations.

Learn how Rebexa Group can be your partner and representative for regulatory affairs services in Central America, the Andean Region, and the Caribbean.

Learn More