Our Approach
Services
FSVP FDA Communication Support
Your Dedicated FSVP FDA Communication and Documentation Support Partner
We support importers by serving as their primary coordination point for FDA communication related to the Foreign Supplier Verification Program. Our PCQI team manages the flow of information during FDA reviews and record requests, helps you organize and prepare documentation, and ensures submissions are accurate and inspection-ready.
What’s included
- Coordination of FDA FSVP record requests
- Review, preparation and organization of documentation needed for FDA submissions
- Timely coordination of relevant documentation
- PCQI-led oversight to ensure documentation aligns with FDA’s FSVP expectations
- Structured communication during FDA reviews and follow-up questions
Deliverables You Receive
- A designated U.S. FSVP representative for FDA communication coordination
- Organized documentation ready to submit to FDA upon request
- Clear instructions on what is needed for each type of inquiry
- Support preparing and presenting FSVP records in a clear, inspection-ready format
How This Supports Compliance
FFDA requires importers to respond promptly and accurately to FSVP record requests. By coordinating communication and preparing documentation on your behalf, we help ensure your FSVP records are complete, well-organized, and aligned with regulatory expectations.
Request a Quote
We offer flexible monthly plans based on your expected FDA communication volume and number of suppliers. Contact us for a quote tailored to your needs.