Successfully submitted over 157 U.S. IND applications
NDA 505(b)(1) Applications - 30
505(b)(2) Applications - 42
FDA Meetings Including All Types (A,B, and C) - 124
Served As US Agent - 61
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Successfully Submitted U.S. IND applications
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Supported Orphan Drug Designation Requests
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Worked on Breakthrough Therapy Designation Requests
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Pediatric Waivers and iPSP
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Special Protocol Assessments (SPAs)
0
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Small Business Waivers
0
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DMF Applications
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Generics (ANDA) Applications