Our first step is to quickly determine which of your products will be covered by the Foreign Supplier Verification Program (FSVP), Hazard Analysis and Risk-Based Preventive Controls (HARPC), Standards from Procedure Safety, and the scope of any possible exemptions. Our second step is to prepare and review all procedures, safety protocols and systems required for the verification process and ensure adequate record-keeping required by the FSVP.
Compliance Mitigation Plan & Rapid Response
International Expertise & Resources
Determination Report & Analysis
The core strategy of FDAeasy.com is to develop customized mitigation plans for importers and suppliers, which anticipates and rapidly responds to decisions from the FDA, making the approval process easy for you.
The FDAeasy.com Team has extensive experience with the US FDA and focused knowledge on the needs and goals of international importers, suppliers, producers, shipping companies, manufacturers, brokers, trade associations and individuals involved in international commerce. Our unique international expertise provides our clients with strategic insights and resources that propel them to the forefront of the world’s rapidly evolving global marketplace.