Regulatory Affairs Consulting Firm Rebexa Opens Headquarters in Mayagüez
SAN JUAN – Pharmaceutical and medical device regulatory affairs consulting firm Rebexa is investing $400,000 on the construction of new headquarters in Mayagüez. The firm, which celebrates its 10th anniversary this year, expects to employ 10 people in 2016.
“This is a very specialized service. There are personnel in pharmaceutical companies dedicated to this but it is not their core competency,” said Commercial Director & Co-founder Naiomi Chardón Saad. “Typically, companies focus on sales and marketing, once the product is registered. But it needs to be registered before it is sold,” explained Chardón. “This is where we found an opportunity.”
Rebexa helps its clients in dealing with the regulatory processes of registering pharmaceutical, veterinary products and medical devices for sale throughout Central America, the Caribbean and the Andean region. The registration process in Latin America is akin to a drug’s approval by the Food and Drug Administration (FDA) in the U.S. A record is submitted with efficacy and safety studies, labeling and how the studies were conducted. In the end, a registration certificate is emitted that typically is valid for 5 years.
The company consolidates all technical product information in Puerto Rico and assembles the files according to the requirements of the countries in which the products will be registered. “The information is then sent to our associates in other countries, which follow up on the process until the registration is completed,” explained Rebexa Founder and President Dr. Arnaldo H. Hernández Jamardo. “Eighty percent of the work is done here in Puerto Rico,” he added.
“We operate in places where it is not probably worth it for a registering company to establish operations but they can get the service through us and sell the product without setting up a dedicated regulatory structure,” Hernández explained.
The company has subsidiaries in Puerto Rico, Costa Rica, Dominican Republic and Ecuador. It focuses on smaller markets and has opted not to compete with existing providers in larger markets such as Mexico, Brazil and Chile, where instead it provides regulatory intelligence services.
According to Hernández, Rebexa’s value proposition rests in its focus on what is a complex and time-consuming process. He also plans on expanding its client base in medical devices and veterinary products, where he sees opportunity for growth.