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

Principal Consultant
CMC Regulatory Affairs
Aimee Cousoulis

Aimee Cousoulis, MS, PMP

Senior Principal Consultant
CMC & Quality
Bettina Donato

Bettina Donato, DABT

Senior Principal Consultant
Nonclinical Safety & Development
Mary E. Dougherty, MS

Mary Dougherty, MS

Associate Principal Consultant
Nonclinical Safety & Development
Cindy Fink

Cynthia Fink, MPH

Advisor
Clinical Development & Regulatory Affairs
Mary Fisher

Mary Fisher

Associate Principal Consultant
CMC & Quality
Madeline Ganton

Madeline Ganton

Associate
Regulatory Operations
Nina LaValley, MSc

Nina Gatto, MSc

Associate
Clinical Development & Regulatory Affairs
Kim Hoefling

Kimberly Hoefling, MS

Principal Consultant
Clinical Development & Regulatory Affairs
Jennifer Jacobson

Jennifer Jacobson, MS

Principal Consultant
Clinical Development & Regulatory Affairs
Abby Kisling

Abigail Kisling, MPH

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, DABT

Director
Nonclinical Safety & Development
Dipali MacAllister

Dipali MacAllister, PharmD, RPh, RAC-US

Senior Principal Consultant
Clinical Development & Regulatory Affairs
Rogelio Martinez Jr., M.S.

Rogelio Martinez Jr, MS

Associate
Nonclinical Safety & Development
Dana Minnick

Dana Minnick, PhD, DABT, RAC-US

Advisor
Nonclinical Safety & Development
Tara Morgen

Tara Morgen

Consultant
CMC & Quality
Brian Mulhern, MS

Brian Mulhern, MS, DABT

Senior Principal Consultant
Nonclinical Safety & Development
Heather Palmer

Heather Palmer

Manager
CMC Regulatory Affairs
Cameron Pierce

Cameron Pierce

Consultant
Clinical Development and Regulatory Affairs
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

Associate Principal Consultant
Clinical Development & Regulatory Affairs
Beth Silverstein, MS, RAC

Beth Silverstein, MS, RAC-US

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

Sarah Smith, MS

Associate Director
Regulatory Operations
Chris Snyder

Christopher Snyder, MS

Senior Consultant
CMC Regulatory Affairs & Regulatory Operations
Vivian Vue

Vivian Vue

Associate
CMC Regulatory Affairs
Emily Wagner, APM

Emily Wagner, PMP

Consultant
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

Senior Advisor
CMC & Quality
Kristy White

Kristy White, MS, PMP, CMCCP

Senior Principal Consultant
CMC Regulatory Affairs
Coua Xiong-Vang, PharmD, MHA

Coua Xiong-Vang, PharmD, MHA

Consultant
Clinical Development & Regulatory Affairs
Sharon Young

Sharon Young, PhD

Associate Principal Consultant
CMC & Quality