EXPERTISE

BROAD DEVELOPMENT EXPERIENCE

• Hands on clinical and industry experience ranging from hospital-based clinical practice to small and medium (virtual, too!) biotechnology and large pharmaceutical companies

• Investigational new drug (IND) & investigational device exemption (IDE) trials conducted globally

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• Small molecules and biologics for parenteral and intraoperative administration

• Phase 0 (pre-development) programs through Phase 4 (post-marketing) clinical trials

• Global regulatory filings, including approved Premarket Approval (PMA) and Marketing Authorization Applications (MAA) for INFUSE® Bone Graft, a first-in-class combination product