Our Professional Consulting Staff Provides Smart and Efficient Solutions

We are a Regulatory Drug Development consulting business that (works exclusively with) serves the needs of small emerging biotechs, most of whom do not yet have major products approved and on the market (to improve performance in strategy and leadership).Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC and Regulatory issues and build programs that enhance development. We are scientific, regulatory program management professionals who work closely with our clients to manage risk and drive development and product registration projects forward as quickly and efficiently as possible.


Project Management


Drug Substance

Drug Product


Quality Assurance

Biologics & Microbiology

Formulation & Clinical Ops