ADVANT
U.S FDA Medical Device Regulatory Guidance.
About
Who we are
Advant is a firm dedicated to liaison between the US FDA Center for Devices and the leadership of Advant’s select clients. Our rich history in managing Clinical Research, Post-Market compliance, and inputs relative to Human Factors in Product design all relate to our complete suite of skills and capabilities in supporting your working relationship with the US FDA and market entrance into the US healthcare system.
Our work with our Clients is managed on our Client’s timelines and time zones, as well as our interface with the US FDA upon theirs as well. Given the diversity of locations of our Clients and their need for up-to-date information and real-time status, we manage all of our work with complete transparency through our Client Portals. Our Client Portals contain the intimate details of our work together, as Advant works for you, our Client, we provide interactive Project Charts and other Cloud-based tools for complete seamless data transfer.
After our Clients successfully receive their US FDA Market Approval
Our work does not stop there. We also provide Market Access support ranging from identifying, qualifying, and assisting in the contracting with the notable US-based Master Distributors, or, if a direct sale market Chanel is preferred, assistance in establishing supply agreements with the larger US-based Group Purchasing Organizations.
From concept to market entrance completion, Advant is with you every step of the way.
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