USA Licensing & Registration

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Streamlined FDA registration for global compliance success.

We simplify the FDA Establishment Registration process for domestic and international facilities involved in the production, preparation, or distribution of drugs, medical devices, and food products. Our team ensures that your registration is completed accurately and on time, providing the FDA with essential information to maintain oversight and safeguard public health. 

We provide comprehensive support for obtaining product state licenses and pharmacy licenses, ensuring your business meets all regulatory requirements to operate legally and confidently. 

From preparing applications to navigating complex state-specific regulations, our team streamlines the licensing process, reduces administrative burdens, and helps you achieve timely approvals. 

We provide expert support for FDA Device Listing, helping manufacturers and distributors register their medical devices with the U.S. Food and Drug Administration. 

Our service ensures that listings are accurate, complete, and compliant with federal requirements, giving your organization confidence in meeting regulatory obligations. By streamlining the process and managing annual updates, we reduce administrative burden while keeping your devices audit-ready and accessible in the U.S. market.

We provide expert guidance for FDA Device Withdrawal and Delisting, helping manufacturers and distributors properly remove medical devices from the FDA’s active database when they are discontinued, rebranded, or no longer marketed in the United States. 

Our service ensures that all required notifications and documentation are submitted accurately, maintaining compliance with federal regulations and avoiding unnecessary regulatory risk.

Our FDA Account Management and Official Correspondence services ensure that your organization maintains accurate, up-to-date records with the U.S. Food and Drug Administration.

 We handle account setup, maintenance, and secure communication on your behalf, streamlining interactions with the FDA while reducing administrative burden. From managing annual updates to responding to regulatory inquiries, we provide reliable oversight and professional correspondence that keeps your business compliant. 

Our FDA Annual Registration Renewal service ensures that your facility remains compliant with U.S. Food and Drug Administration requirements year after year. We manage the entire renewal process—updating establishment information, submitting documentation, and confirming deadlines—so your registration stays active and audit-ready. 

By streamlining renewals and reducing administrative burden, we help manufacturers, distributors, and importers maintain uninterrupted market access.