International organizations looking to sell or distribute pharmaceutical products in the U.S. are required by law to designate a U.S. Agent. DSI serves as your trusted U.S. Agent, providing critical support to ensure compliance with all applicable FDA regulations and acting as a reliable point of contact between your organization and the FDA.
Responsibilities of a U.S. agent
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours.
The responsibilities of the U.S. agent are limited and include:
- assisting FDA in communications with the foreign establishment,
- responding to questions concerning the foreign establishment's devices that are imported or offered for import into the United States,
- assisting FDA in scheduling inspections of the foreign establishment and
- if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.
What is a U.S. Agent?
A U.S. Agent is a representative designated by foreign companies to act as the official point of contact with the FDA. This role is crucial for ensuring compliant establishment registration and effective communication with regulatory authorities, as mandated by Sec. 207.69 of FDA regulations.
- The U.S. Agent must be physically located within the United States (including Puerto Rico or a U.S. territory).
- The U.S. Agent can be an individual, partnership, corporation, or association.
- The agent must agree to serve in this capacity and fulfill the required responsibilities.
How DSI Supports Your U.S. Regulatory Needs:
Designate an Official Contact: We act as your primary point of contact with the FDA for all regulatory matters related to establishment registration and product compliance.
Assist with Registration and Listing: Our team ensures that your establishment registration and product listings are accurate and compliant with FDA requirements.
Centralize Communication Management: We handle all FDA correspondence, including emergency communications, to streamline and manage regulatory interactions.
Coordinate Inspection and Compliance: DSI liaises with the FDA to facilitate inspection scheduling, response management, and overall regulatory compliance.
Ad-Hoc Regulatory Consulting: We offer on-demand consulting services for regulatory compliance, addressing FDA inquiries, assessing compliance risks, and advising on appropriate responses.
Why Choose DSI as Your U.S. Agent?
Expert Guidance: With extensive experience in regulatory affairs, DSI provides unparalleled support to navigate complex FDA regulations.
Reliable Representation: We act as your dedicated representative, ensuring clear and effective communication with the FDA.
Comprehensive Support: From initial registration to ongoing compliance management, we offer a full spectrum of services tailored to your needs.
Contact us today at solutions@dsinpharmatics.com to learn more about how DSI can serve as your U.S. Agent and ensure your products remain compliant with FDA regulations.
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Global Regulatory Operations Offerings
eCTD Publishing Services:
Our eCTD (Electronic Common Technical Document) publishing services streamline the submission process for regulatory approvals. We handle the meticulous compilation, validation, and submission of eCTD dossiers to ensure compliance with global regulatory standards. Our team is skilled in converting complex data into the required formats, managing lifecycle submissions, and providing strategic support throughout the submission process, ensuring your regulatory journey is seamless and efficient.
Labeling Services:
Our labeling services encompass the creation, review, and management of compliant product labeling, including prescribing information, patient leaflets, and packaging artwork. We ensure that all labeling components meet the latest regulatory requirements and are aligned with your product’s global strategy. Our experts support the entire lifecycle of labeling activities, from initial development to post-approval updates, ensuring clarity, accuracy, and compliance.
