Who we are
PharmaCRO, LLC provides product development services to help early stage and established firms develop innovative medical devices, drug delivery systems and combination medical products. We work in close partnership with our clients to define needs and develop and execute a plan that meets the desired goals on time and on budget.
We offer a unique perspective that integrates design, manufacturing, regulatory, clinical, toxicology, and marketing requirements to identify the least burdensome and most efficient route to development, approval and commercialization of safe, reliable and proprietary products. Our international experience includes working with companies in Europe and Asia.
PharmaCRO, LLC was founded by Pravin Soni, PhD who has over forty-two (42) years of industrial experience developing and bringing to market a broad range of products including medical devices, drug products, drug delivery systems and combination products. Dr. Soni received his PhD from Case Western Reserve University and has held senior positions at Raychem Corporation, Cygnus Inc, Alexza Pharmaceuticals, and Elevation Pharmaceuticals, which was acquired by Sunovion. He was co-founder of Patara Pharma which was acquired by Roivant Sciences and spun-off as a Division, Respivant Sciences. Dr. Soni is co-inventor on sixty-three (63) US and foreign patents and he has co-authored twenty-three (23) peer reviewed journal articles and poster presentations.
What we do
Areas of product development expertise (please visit our Services page for details)
Medical Device Development
- Definition of need
- Design
- Manufacturing
- Regulatory strategy, compliance and Agency interactions
Drug and Combination Medical Product Development
- Definition of need
- Formulation and pre-clinical development
- Design and manufacturing
- Regulatory strategy, compliance and Agency interactions
