Registrar Corp is a leading provider of FDA agent services, ensuring compliance for businesses operating in the United States.
Registrar Corp specializes in providing essential services for companies needing to comply with U.S. Food and Drug Administration (FDA) regulations. As a dedicated FDA agent, they act as a crucial liaison between foreign and domestic businesses and the FDA, facilitating communication and ensuring all regulatory requirements are met. Their expertise covers a wide range of FDA-related needs, including registration and listing, product submissions, and regulatory consulting. By leveraging Registrar Corp's services, businesses can navigate the complex landscape of FDA compliance with confidence, minimizing risks and accelerating market entry. They are committed to offering efficient and reliable solutions tailored to the specific needs of each client, making them a trusted partner in the pharmaceutical, medical device, and food industries.
About
**Who they are** Registrar Corp is a dedicated provider of FDA U.S. Agent services, assisting international businesses in meeting their regulatory obligations for operating in the United States. They focus on ensuring compliance for companies that need to appoint a U.S. Agent.
**Expertise & scope** * Specializes in FDA U.S. Agent representation. * Facilitates compliance for businesses importing products into the U.S. market. * Provides services in English and Spanish.
**Reputation / proof points** * Established provider of FDA agent services.
Additional information
For businesses seeking to comply with FDA regulations, appointing a U.S. Agent is a critical step. Registrar Corp streamlines this process by acting as the official point of contact for the FDA. This ensures that communication between the agency and your company is managed efficiently, helping to avoid potential delays or issues with product entry into the U.S. Their service is designed to support companies that may not have a physical presence in the United States, providing a reliable and professional representation.
Industries: Foods, Cosmetics, Medical devices, Drugs
Portfolio: 100+
Onboarding time: 1–3 days
Pricing model: Retainer
Starting from: USD 1,500
Included services: FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Product Type: food, drugs
Service Types: US Agent Services, FDA Registration/Listing Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Appointment as U.S. Agent, facilitation of FDA establishment registration and device listing.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).