Our Professional Staff Provides Smart and Efficient Solutions

We are scientific and regulatory professionals who work closely with our clients to manage risk and drive development and product registration projects forward as quickly and efficiently as possible.

Scientific & Regulatory Consultants

Melanie S. Bell, MS, RAC

Melanie Bell, MS, RAC

Associate Principal Consultant
CMC Regulatory Affairs
Christine Berardi, Ph.D

Christine Berardi, PhD

Associate Principal Consultant
Clinical Development & Regulatory Affairs
Laura Crawford

Laura Crawford, PhD, DABT, RAC

Associate Principal Consultant
Nonclinical Safety & Development
Donato J Bettina, DABT

Bettina Donato, DABT

Senior Principal Consultant
Nonclinical Safety & Development
Beth Farinha, MS

Beth Farinha, MS

Associate Principal Consultant
CMC, Compliance & Quality
Cynthia A. Fink, MPH, RAC (Cindy)

Cynthia Fink, MPH

Advisor
Clinical Development & Regulatory Affairs
Lauren Herron

Lauren Herron

Consultant
Clinical Development & Regulatory Affairs
Kimberly Hoefling, MS. Areas of Expertise Quality & Compliance, Regulatory Affairs

Kimberly Hoefling, MS

Associate Principal Consultant
Clinical Development & Regulatory Affairs
Jennifer Jacobson, MS

Jennifer Jacobson, MS

Principal Consultant
Clinical Development & Regulatory Affairs
Abigail Kisling

Abigail Kisling

Consultant
Regulatory Operations
Jeffrey Klein, Ph.D.

Jeffrey Klein, PhD, DABT

Advisor
Nonclinical Safety & Development
Dan Krietlow

Daniel Krietlow, MA

Senior Consultant
Nonclinical Safety & Development
Nicole Lay, MS

Nicole Lay, MS

Associate Director
Nonclinical Safety & Development
Jackie LoSchiavo, MS

Jackie LoSchiavo, MS

Consultant
CMC, Compliance & Quality
Dipali MacAllister, PharmD, RPh

Dipali MacAllister, PharmD, RPh, RAC

Principal Consultant
Clinical Development & Regulatory Affairs
Jaymeth E. Maddox

Jaymeth Maddox

Principal Consultant
CMC, Compliance & Quality
Dana Minnick

Dana Minnick, PhD, DABT, RAC

Advisor
Nonclinical Safety & Development
Tara Morgen

Tara Morgen

Associate
CMC, Compliance & Quality
Brian Mulhern, MS

Brian Mulhern, MS

Principal Consultant
Nonclinical Safety & Development
Heather Palmer

Heather Palmer

Manager
CMC Regulatory Affairs
Cameron H. Pierce

Cameron Pierce

Associate
Nonclinical Safety & Development
Sara Price, MA

Sara Price, MA

Senior Consultant
Nonclinical Safety & Development
Jeff Pudlo

Jeff Pudlo, PhD

Advisor
CMC, Compliance & Quality
Rajan Ramaswami, PhD

Rajan Ramaswami, PhD

Advisor
CMC, Manufacturing & Development
Isabella Rossi

Isabella Rossi

Consultant
CMC, Compliance & Quality
Danielle Ruiz, MS

Danielle Ruiz, MS, RAC

Senior Consultant
Clinical Development & Regulatory Affairs
Beth Silverstein, MS, RAC

Beth Silverstein, MS, RAC

Senior Scientific Advisor
Clinical Development & Regulatory Affairs
Sarah Smith, MS

Sarah Smith, MS

Manager
Regulatory Operations
Christopher Snyder, MS

Christopher Snyder, MS

Consultant
CMC Regulatory Affairs & Regulatory Operations
Emily Wagner, APM

Emily Wagner, APM

Associate
CMC Regulatory Affairs
Stacie Wehling, MSCR, RAC

Stacie Wehling, MSCR, RAC

Manager
Clinical Development & Regulatory Affairs
Cara Weyker, MBA. Areas of Expertise Manufacturing & Development, Quality & Compliance

Cara Weyker, MBA

Advisor
CMC, Compliance & Quality
Kristy V. White, M.S., PMP, CMCCP

Kristy V. White, MS, PMP, CMCCP

Principal Consultant
CMC Regulatory Affairs
Sara Wong, MSc

Sara Wong, MSc

Associate
Clinical Development & Regulatory Affairs
Sharon L. Young, Ph.D.

Sharon L. Young, PhD

Associate Principal Consultant
CMC, Compliance & Quality