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PharmaRegs Puerto Rico Registrations

PharmaRegs Puerto Rico, a sister company of State License Servicing, Inc., is a certified Representative Agent registered with the Puerto Rico Secretary of Health, specializing in the island’s unique pharmaceutical regulatory landscape. We offer a full suite of services, including drug and device product registrations, non-resident licenses, and regulatory filings. Our expertise ensures seamless navigation of local compliance requirements, helping pharmaceutical companies efficiently bring their products to market while maintaining full regulatory compliance.

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About PharmaRegs Puerto Rico

PharmaRegs Puerto Rico specializes in navigating the island’s complex regulatory landscape, ensuring pharmaceutical companies achieve and maintain full compliance. Our services include obtaining Non-Resident Virtual Manufacturer Licenses, Non-Resident Wholesale Distributor Licenses, and Drug Product and Medical Device Registrations. We also provide Non-Resident Drug Distributor Bond services, DOH SARAFS License verification, and Secretary of State/SUT filings, offering a comprehensive solution for businesses looking to enter or expand within the Puerto Rican market.

In Puerto Rico, every prescription and OTC product must be registered with the central government through a licensed local representative agent of the manufacturer. As a trusted certified Representative Agent, we streamline this process with our searchable Product Registration Database, ensuring compliance with all local regulations. Our dedicated team, powered by Human Intelligence (HI), provides personalized support, making regulatory navigation seamless and efficient. Contact us today for a customized proposal detailing our services, costs, and fees!

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Our Services Include

Non-Resident Virtual Manufacturer License

We facilitate licensing for companies manufacturing products outside Puerto Rico but selling within the territory.

Non-Resident Wholesale Distributor License

We assist companies in obtaining licenses to wholesale distribute pharmaceutical products in Puerto Rico.

Drug Product Registrations

We support the registration of prescription and over-the-counter drugs with the Puerto Rican government.

Medical Device Registrations

We manage the registration process for medical devices to ensure compliance with Puerto Rican regulations.

Secretary of State/SUT Filings

We manage filings with the Secretary of State and Sales and Use Tax (SUT) to maintain compliance.

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Puerto Rico DOH SARAFS License Verification Services

We offer verification services to ensure compliance with Department of Health requirements.

Non-Resident Drug Distributor Bond

We provide the necessary bond to ensure compliance for non-resident distributors operating in Puerto Rico.

Searchable Product Registration Database

We provide access to a database for easy searching of registered pharmaceutical products in Puerto Rico.

Select your business model to see how we can support your work with our expertise!

Your Security is Our Priority

By implementing stringent security protocols, we enhance data protection by incorporating:

  • ISO 27001/SOC2 Compliant Platforms
  • Multi-Factor Authentication (MFA)
  • Data Encryption
  • Network Encryption
  • SSL & Firewall Protections
  • Strict Access Control
  • Endpoint Security

Client Testimonials

Carlos M., Device Distributor

“PharmaRegs made what could’ve been a complicated registration process incredibly smooth. Their team was responsive, knowledgeable, and helped us navigate the Puerto Rico requirements with ease.”

Denise F., Repackager

“From document prep to final approval, their communication and expertise were on point. I’d work with them again in a heartbeat!”

Michael T., Virtual Manufacturer

“As a virtual manufacturer, compliance in Puerto Rico was unfamiliar territory. PharmaRegs guided us step-by-step, answering every question and handling the entire process. Their team is a true partner in our Puerto Rico operations.”

Angela R., Wholesale Distributor

“We’ve worked with several consultants over the years trying to get our licenses to operate in Puerto Rico but PharmaRegs stands far and above the rest. Highly recommend for anyone in the wholesale space.”

Javier L., Third-Party Logistics Provider

“Getting our 3PL registered in Puerto Rico was a breeze with PharmaRegs. They know the system inside out and saved us weeks of back-and-forth. Solid service, professional team.”