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  • The FDA Annual Establishment Registration User Fee (FY 2024) is a mandatory fee required from all facilities that are regulated by the FDA. This fee is essential for ensuring that our clients' establishments remain in compliance with FDA regulations. By purchasing this fee, we will be able to submit the annual establishment registration on our clients' behalf and pay the FDA user fee. This is a crucial step in maintaining our clients' FDA compliance and avoiding potential legal and financial consequences.


  • Our Official Correspondent / Regulatory Contact Service offers a reliable and professional service to ensure that all communication with the FDA is handled efficiently and effectively. Our experienced team is well-versed in FDA regulations and can provide expert guidance and support to ensure compliance and timely response to any inquiries or submissions. We understand the importance of maintaining compliance and building strong relationships with regulatory agencies, and our service is designed to help our clients achieve these goals. With our Official Correspondent and Regulatory Contact Service, you can have peace of mind knowing that your regulatory communications are in good hands.


  • Our FDA Device Listing service is a must-have for any company distributing medical devices in the US. Our experienced consultants will ensure that all of your devices are listed with the FDA in compliance with the appropriate regulatory requirements. With our expertise, we can accurately analyze and determine which regulations your device falls under, saving you valuable time and resources. Trust our team to handle all of your FDA Device Listing needs and ensure your company's compliance with federal regulations.


  • Our FDA US Agent Service is an essential resource for foreign companies seeking to navigate the complex regulatory environment of the US Food and Drug Administration. As the official point of contact, our experienced consultants provide expert guidance and support throughout the engagement with the FDA officials. We assist in understanding regulations, represent your interests, respond to FDA inquiries, and help you navitate through compliance issues. With our reliable and efficient service, you can trust that your company is in good hands. 


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