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Your biggest challenge will be the approval process. We can help. At ECG, we have worked with the leading international healthcare companies to develop and refine their strategies for shepherding newly developed drugs, biologics, medical devices and vaccines through the regulatory process. To date, we have helped prepare teams for 42 successful FDA Advisory Committee meetings. We have also assisted teams in preparing for meetings with numerous international health authorities including Health Canada, CHMP, KIKO, and the Chinese Ministry of Health. We helped 8 teams successfully prepare for Special Issue hearings where the intended outcome is not approval but, rather, regulatory guidance or a new pathway. And we helped get more than 12 products approved where hearings were cancelled due to the success of interim communications with health authorities that grew directly out of our preparatory process. We can help you succeed, too. For more information, please contact Frank Carillo, our Managing Director, via email at frank@ecglink.com or by telephone |
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