U.S. Agent Services

As your liaison to the FDA, we will work effectively with your firm to facilitate filings and information requests from the FDA to help avoid delays with product approvals.  We will work in partnership with your firm to identify issues and help support a positive inspection outcome.

• Liaison with the FDA and clients to support timely approvals of submitted applications and help to navigate quickly through any developing issues
• Provide support and guidance with regard to FDA administration regulations
• Facilitation of client meetings with the FDA
• Coordination of foreign facility inspections by the FDA
• Filing of foreign establishments and registration updates as changes occur

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