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.
Leadership Team
Edward Narke
Principal
Anthony Durning
Principal
Brian Lihou
Head of Operations
Anne Carr
Head of Finance & Administration
Meranda Parascandola
Head of Business Development and Marketing
Tom Hoy
Head of Project Management
Eileen Jacobs
Senior Project Management Consultant
Rick Offerman
Senior Project Management Consultant
Dennis Roberts
Senior Project Management Consultant
David Blasingame
Senior Project Management Consultant
Paul Long
Project Management Consultant
Timothy Lloyd Trapp
Senior Project Management Consultant
Analytical Services
Colman Byrne
Head of Analytical Services
Anil Raghani
Senior Analytical Development Consultant
James Klancke
Senior Analytical Development Consultant
Drug Substance Services
Daniel Torok
Senior Drug Substance Consultant
James Mencel
Senior Drug Substance Consultant
David Adams
Senior Drug Substance Consultant
Christopher Brookes
Senior Drug Substance Consultant
Drug Product Services
Kyriakos Michailaros
Head of Drug Product Services
Nancy Harper
Senior Drug Product Consultant
Prasad Gullapalli
Senior Drug Product Consultant
Alpaslan Yaman
Senior Drug Product Consultant
Regulatory Services
Catherine Bernard
Senior Regulatory Affairs Consultant
Amy McCord
Senior Regulatory Affairs Consultant
Randall Lis
Senior Regulatory Affairs Consultant
Quality Assurance Services
Robbi Freisem
Senior Quality Assurance Consultant
Bettina Kaplan
Senior Quality Assurance Consultant
Susan Fasso
Senior Quality Assurance Consultant
Maria Arakil
Quality Assurance Consultant
Biologics & Microbiology Services
Les Mintzmyer
Senior Biologics Manufacturing Consultant
Michael Carroll
Senior Consultant, Microbiologist
Supply Chain Services
Jason Bender
Head of Supply Chain Services
Johanna Karas
Senior Supply Chain Consultant
Amanda Goodman
Supply Chain Consultant
Early Program Services
Judy Magruder
Senior Program Development Consultant