Meet our Subject Matter Experts

Adam Kopel

Assistant Interventionalist

Interventional & Surgical Research, Preclinical

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

Alfred Dibao-Dina, PhD

Biological Safety Scientist

Biocompatibility, Biological Safety

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

Ariadna Navarro, PhD

Senior Strategy Consultant

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

Aurélie San Juan, MSc, PhD

Principal Medical Writer, Regulatory

EU MDR, Medical Writing, Regulatory

Barb Mercier

Associate Manager, Clinical Research Associates

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

Caroline Guidicelli

Caroline Guidicelli, MSc, MEng

Principal Medical Writer

EU MDR, Medical Writing, Regulatory

Catherine Tremolieres, DVM

Manager, Biological Safety & Validation Consulting Services, Europe

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

Cayla Ruch, PhD, DABT

Biocompatibility, Toxicology

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