We are uniquely positioned to provide a comprehensive and scalable suite of services to develop therapeutic drugs and devices with cost-efficient predictability. We have the expertise to support lifecycle strategies that drive product value, extend market share, and maximize ROI.
Avoid the “large CRO shuffle” – We offer cost efficient, fully integrated expertise and services from start to finish.
NAVIGATING YOUR PATHWAY TO SUCCESS
We bridge the
“Valley of Death”
and accelerate research
Our unique SmartStart™ Access program lets companies leverage our existing suite of integrated services and growth strategies to develop and commercialize products.
UNPARALLELED SUCCESS FROM DISCOVERY TO COMMERCIALIZATION
- Commercialized over 500 new drugs, biologics, medical devices and in-vitro diagnostics
- Over 250 medical device 510(k) Class 1-3 submissions with 100% success
- Extensive Orphan, “First in Class,” and “First In” Indication success.
- Reduced time to approval by over 600 days
- Over 100 NDA, ANDA and BLA submissions, with 96% success
- Greater than 60 EMA CHMP Marketing Authorizations
- SmartStudy™ design and feasibility assessments enhanced study efficiency and success and reduced protocol amendments by over 50%