Our regulatory and compliance team team includes former senior executives from the U.S. government and senior level policy analysts, researchers, and engineers. These experts offer direction pertaining to federal guidelines, standards, and regulations, as well as provide guidance on how these guidelines, standards, and regulations will develop.

Our team’s intimate knowledge and understanding of complex government rule-making, engineering and legislative processes, and procedures enable ESI to provide a broad range of services to our clients.

ESI goes deeper than regulatory assistance by including the depth of knowledge from our team of engineers and scientists, including chemists, polymer scientists, metallurgists, materials scientists, mechanical engineers, electrical engineers, biomechanical engineers and statisticians.

To learn more about ESI, visit our main website.

Meet Our Team

Jennifer D. Ahearn

Director, Pharmaceutical and Medical Devices

Ms. Ahearn has worked with manufacturers with such aspects as sterility, material supply chain, vendor auditing, validation...

David A. Pederson

Senior Consultant

Mr. Pederson manages and collaborates with multidisciplinary teams of scientists and engineers to solve problems with manufacturing...

Daniel R. Spankie

Senior Consultant

Mr. Spankie specializes in pharmaceutical and medical device regulatory compliance and has over 19 years of experience in...