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.
Leadership
Administration
Scientific & Regulatory Consultants

Melanie Bell, MS, RAC-Drugs
Associate Principal Consultant
CMC Regulatory Affairs
CMC Regulatory Affairs

Aimee Cousoulis, M.S., PMP
Principal Consultant
CMC & Quality
CMC & Quality

Bettina Donato, DABT
Senior Principal Consultant
Nonclinical Safety & Development
Nonclinical Safety & Development

Beth Farinha, MS
Associate Principal Consultant
CMC & Quality
CMC & Quality

Cynthia Fink, MPH
Advisor
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Lauren Herron
Consultant
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Kimberly Hoefling, MS
Associate Principal Consultant
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

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

Abigail Kisling
Consultant
Regulatory Operations
Regulatory Operations

Jeffrey Klein, PhD, DABT
Advisor
Nonclinical Safety & Development
Nonclinical Safety & Development

Daniel Krietlow, MA
Senior Consultant
Nonclinical Safety & Development
Nonclinical Safety & Development

Nicole Lay, MS
Associate Director
Nonclinical Safety & Development
Nonclinical Safety & Development

Phynese Lewis, CQA (ASQ), LSSGB
Associate Principal Consultant
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Jackie LoSchiavo, MS
Consultant
CMC & Quality
CMC & Quality

Dipali MacAllister, PharmD, RPh, RAC-US
Principal Consultant
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Jaymeth Maddox
Principal Consultant
CMC & Quality
CMC & Quality

Dana Minnick, PhD, DABT, RAC-US
Advisor
Nonclinical Safety & Development
Nonclinical Safety & Development

Laura Mondano, B.S., RAC-US
Advisor
Regulatory Affairs
Regulatory Affairs

Tara Morgen
Associate
CMC & Quality
CMC & Quality

Brian Mulhern, MS
Principal Consultant
Nonclinical Safety & Development
Nonclinical Safety & Development

Heather Palmer
Manager
CMC Regulatory Affairs
CMC Regulatory Affairs

Cameron Pierce
Associate
Nonclinical Safety & Development
Nonclinical Safety & Development

Sara Price, MA
Senior Consultant
Nonclinical Safety & Development
Nonclinical Safety & Development

Jeff Pudlo, PhD
Advisor
CMC & Quality
CMC & Quality

Rajan Ramaswami, PhD
Advisor
CMC & Quality
CMC & Quality

Isabella Rossi
Consultant
CMC & Quality
CMC & Quality

Danielle Ruiz, MS, RAC-US
Senior Consultant
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Beth Silverstein, MS, RAC-US
Senior Scientific Advisor
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Sarah Smith, MS
Manager
Regulatory Operations
Regulatory Operations

Christopher Snyder, MS
Consultant
CMC Regulatory Affairs & Regulatory Operations
CMC Regulatory Affairs & Regulatory Operations

Emily Wagner, APM
Associate
CMC Regulatory Affairs
CMC Regulatory Affairs

Stacie Wehling, MSCR, RAC-US
Manager
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Cara Weyker, MBA
Advisor
CMC & Quality
CMC & Quality

Kristy V. White, MS, PMP, CMCCP
Principal Consultant
CMC Regulatory Affairs
CMC Regulatory Affairs

Eliav Winton
Associate
Nonclinical Safety & Development
Nonclinical Safety & Development

Sara Wong, MSc
Associate
Clinical Development & Regulatory Affairs
Clinical Development & Regulatory Affairs

Sharon L. Young, PhD
Associate Principal Consultant
CMC & Quality
CMC & Quality