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-Drugs

Associate Principal Consultant
CMC Regulatory Affairs
Aimee Cousoulis

Aimee Cousoulis, M.S., PMP

Principal Consultant
CMC & Quality
Bettina Donato

Bettina Donato, DABT

Senior Principal Consultant
Nonclinical Safety & Development
Beth Farinha

Beth Farinha, MS

Associate Principal Consultant
CMC & Quality
Cindy Fink

Cynthia Fink, MPH

Advisor
Clinical Development & Regulatory Affairs
Lauren Herron

Lauren Herron

Consultant
Clinical Development & Regulatory Affairs
Kim Hoefling

Kimberly Hoefling, MS

Associate Principal Consultant
Clinical Development & Regulatory Affairs
Jennifer Jacobson

Jennifer Jacobson, MS

Principal Consultant
Clinical Development & Regulatory Affairs
Abby Kisling

Abigail Kisling

Consultant
Regulatory Operations
Jeff Klein

Jeffrey Klein, PhD, DABT

Advisor
Nonclinical Safety & Development
Dan Krietlow

Daniel Krietlow, MA

Senior Consultant
Nonclinical Safety & Development
Nicole Lay

Nicole Lay, MS

Associate Director
Nonclinical Safety & Development
Phynese Lewis

Phynese Lewis, CQA (ASQ), LSSGB

Associate Principal Consultant
Clinical Development & Regulatory Affairs
Jackie Loschiavo

Jackie LoSchiavo, MS

Consultant
CMC & Quality
Dipali MacAllister

Dipali MacAllister, PharmD, RPh, RAC-US

Principal Consultant
Clinical Development & Regulatory Affairs
Jaymeth Maddox

Jaymeth Maddox

Principal Consultant
CMC & Quality
Dana Minnick

Dana Minnick, PhD, DABT, RAC-US

Advisor
Nonclinical Safety & Development
Laura Mondano

Laura Mondano, B.S., RAC-US

Advisor
Regulatory Affairs
Tara Morgen

Tara Morgen

Associate
CMC & Quality
Brian Mulhern, MS

Brian Mulhern, MS

Principal Consultant
Nonclinical Safety & Development
Heather Palmer

Heather Palmer

Manager
CMC Regulatory Affairs
Cameron Pierce

Cameron Pierce

Associate
Nonclinical Safety & Development
Sara Price

Sara Price, MA

Senior Consultant
Nonclinical Safety & Development
Jeff Pudlo

Jeff Pudlo, PhD

Advisor
CMC & Quality
Rajan Ramaswami

Rajan Ramaswami, PhD

Advisor
CMC & Quality
Isabella Rossi

Isabella Rossi

Consultant
CMC & Quality
Danielle Ruiz

Danielle Ruiz, MS, RAC-US

Senior Consultant
Clinical Development & Regulatory Affairs
Beth Silverstein

Beth Silverstein, MS, RAC-US

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

Sarah Smith, MS

Manager
Regulatory Operations
Chris Snyder

Christopher Snyder, MS

Consultant
CMC Regulatory Affairs & Regulatory Operations
Emily Wagner

Emily Wagner, APM

Associate
CMC Regulatory Affairs
Stacie Wehling

Stacie Wehling, MSCR, RAC-US

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

Cara Weyker, MBA

Advisor
CMC & Quality
Kristy White

Kristy V. White, MS, PMP, CMCCP

Principal Consultant
CMC Regulatory Affairs
Eliav Winton

Eliav Winton

Associate
Nonclinical Safety & Development
Sara Wong

Sara Wong, MSc

Associate
Clinical Development & Regulatory Affairs
Sharon Young

Sharon L. Young, PhD

Associate Principal Consultant
CMC & Quality