Regulatory Affairs Services for Pharmaceutical Products in Puerto Rico, Central America, the Andean Region, and the Caribbean
Rebexa Group offers vast knowledge of the pharmaceutical industry, as well as registration and regulatory expertise, to suit your company’s exact needs related to the local compliance efforts for medications.
From registration dossier preparation and registration life-cycle management, to pharmacovigilance support in the Puerto Rican, Central America, Andean and Caribbean regions, Rebexa Group is your partner for outsourced regulatory compliance services.
Compliance requirements for pharma products
Puerto Rico is one of the world’s top manufacturing sites for pharmaceutical products and advantageously located between North and South America. Rebexa Group’s headquarters are strategically located on the island to facilitate access to pharmaceutical industry resources for our clients. Currently we manage regulatory affairs for pharmaceutical products in a wide array of therapeutic areas.
Registration Representation in Puerto Rico
Puerto Rico regulations require health product registrations to be represented by a local legal entity with an active license in the Department of Health. Rebexa Group provides the use of its Representative Agent license to host our client’s product registrations at the Department of Health. The registration of pesticides with the Dept. of Agriculture also requires also requires local representations which Rebexa can provide.
As local agents, Rebexa Group complies with every requirement and established government regulations, providing our clients the trust and legal formality these processes demand. We act as a local contact between companies and the Department of Health. We take care of all the necessary procedures related to registered products.
Rebexa Group is a single source entity and one-stop shop for registration, technical and compliance services of your products in Puerto Rico, as well as the Caribbean Basin.
Please contact us for more information about regulatory affairs services for pharmaceutical products in Puerto Rico, Costa Rica, Dominican Republic, Ecuador or the Caribbean market.