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

Senior Consultant
CMC, Compliance & Quality
Christine Berardi, Ph.D

Christine Berardi, Ph.D.

Senior Consultant
Clinical Development & Regulatory Affairs
Beth Farinha, MS

Beth Farinha, MS

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

Cynthia Fink, MPH, RAC

Principal Consultant
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

Senior Consultant
Clinical Development & Regulatory Affairs
Jennifer Jacobson, MS

Jennifer Jacobson, MS

Principal Consultant
Clinical Development & Regulatory Affairs
Jeffrey Klein, Ph.D.

Jeffrey Klein, Ph.D., DABT

Principal Consultant
Toxicology, Nonclinical Safety & Development
Dan Krietlow

Daniel Krietlow, MA

Consultant
Nonclinical Safety & Development
Molly Lausten. Area of expertise Regulatory Operations

Molly Lausten

Associate
Clinical Development & Regulatory Affairs
Nicole Lay, MS

Nicole Lay, MS

Senior Consultant
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

Senior Consultant
CMC, Compliance & Quality
Christina Malin

Christina Malin

Senior Consultant
CMC, Compliance & Quality
Dana Minnick

Dana Minnick, PhD, DABT, RAC

Principal Consultant
Nonclinical Safety & Development
Tara Morgen

Tara Morgen

Associate
CMC, Compliance & Quality
Brian Mulhern, MS

Brian Mulhern, MS

Senior Consultant
Nonclinical Safety & Development
Heather Palmer

Heather Palmer

Senior Consultant
CMC, Compliance & Quality
Cameron H. Pierce

Cameron Pierce

Associate
Nonclinical Safety & Development
Laura Pitzonka

Laura Pitzonka, Ph.D., DABT, RAC

Senior Consultant
Nonclinical Safety & Development
Sara Price, MA

Sara Price, MA

Consultant
Nonclinical Safety & Development
Jeff Pudlo

Jeff Pudlo, PhD

Principal Consultant
CMC, Compliance & Quality
Isabella Rossi

Isabella Rossi

Associate
CMC, Compliance & Quality
Danielle Ruiz, MS

Danielle Ruiz, MS, RAC

Senior Consultant
Clinical Development & Regulatory Affairs
Bonnie Sadow

Bonnie Sadow

Director
CMC, Compliance & Quality
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, Compliance & Quality
Stacie Wehling, MSCR, RAC

Stacie Wehling, MSCR, RAC

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

Cara Weyker, MBA

Principal Consultant
CMC, Compliance & Quality
Abigail Wilkins

Abigail Wilkins

Document Specialist
Regulatory Operations
Sharon L. Young, Ph.D.

Sharon L. Young, Ph.D.

Senior Consultant
CMC, Compliance & Quality