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SOLUTIONS
Nonclinical PK/ADME & Safety
Clinical Pharmacology & Modeling
Behavioral Pharmacology
EXPERIENCE
200+
small molecule bioanalytical methods developed
200+
nonclinical PK studies analyzed and reported
50+
GLP toxicokinetic (TK) studies analyzed and reported
75+
Clinical Pharmacology/PK study analyzed and reported
15
end-of-phase 2 meetings
30+
bioanalytical methods developed and validated
25+
505(b)1 and 505(b)2 PreIND meetings
30+
505(b)1 and 505(b)2 IND submissions
15+
505(b)1 and 505(b)2 NDA submissions
1
FDA Advisory Committee Meeting
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