Meet our Subject Matter Experts

Adam Saltman, PhD, MD

Principal Strategy Consultant, Clinical and Regulatory Services

Clinical, FDA, Product Development, Regulatory

Áine Mary Duffy, BSc (Hons), PhD

Clinical & Regulatory Operations Manager

Clinical, EU MDR, FDA, Medical Writing, Regulatory

Alexander Hermann, PhD

Supervisor, Study Director Group

Biological Safety, Chemical Characterization, FDA

Andy J. Wyen, MS, DABT, LAT

Principal Toxicologist

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Toxicology

Angela Sanchez

Associate Scientific Director, Analytical Services

Chemical Characterization, EU MDR, FDA

Brandon Woll, MBA

Principal Strategy Consultant

Director, FDA, Preclinical, Product Development, Quality, Regulatory, Validation

Carla Wiese

Carla M. Wiese, BS-Mech Eng

Principal Strategy Consultant, Regulatory

FDA, Product Development, Regulatory

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

Biocompatibility, Biological Safety, Chemical Characterization, EU MDR, FDA, Regulatory, Toxicology

Chris Mullin

Chris Mullin, MS

Director, Global Strategy Services

Biostatistics, Clinical, FDA, Product Development, Regulatory

Christèle East, PhD

Christèle East, PhD

Senior Regulatory Consultant, IVD

Clinical, EU IVDR, FDA, IVD, Medical Writing, Quality, Regulatory

Corey Leet

Director, Regional Preclinical and In-Vivo Biocompatibility Operations

Director, FDA, Interventional & Surgical Research, Preclinical

Don Pohl, BS

Principal Strategy Consultant, Biocompatibility

Biocompatibility, Biological Safety, EU MDR, FDA, Regulatory

Ed Arscott, BS

Principal Strategy Consultant, Microbiology

FDA, Microbiology, Product Development, Validation

Frédéric Cadoret, PhD

Senior Study Director, Sterility Assurance

FDA, Microbiology, Notified Body Expertise, Validation

Gaëlle Clermont, PharmD, PhD

Principal Strategy Consultant

Biological Safety, EU MDR, FDA, Medical Writing, Preclinical, Product Development, Regulatory

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