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Experts

Maciej Jakucki

Maciej Jakucki has performed and managed a wide variety of medical testing projects and programs to meet FDA and CE requirements.
Experts

Tom Elson

Meet our Digital Engineering expert Tom Elson and learn more about his expertise in CFD which enhances our projects with innovative solutions.
Experts

Mark Perkins

Senior Application Chemist with over 22 years of experience in Analytical Chemistry, focusing on the development of SIFT-MS applications.
Experts

Michael Derby

Michael Derby has been in the product development and approvals business for more than 35 years. His present area of expertise is helping manufacturers get radio equipment onto the market.
Experts

Mark Elliott

With almost 30 years of experience, Mark is instantly recognizable in the emissions industry. He brings reliable, honest and insightful decision-making expertise to the table, and demands a culture of safety within the team.
Experts

Nicole Small

Nicole is a highly experienced regulatory professional with a depth and breadth of experience in the safety, performance, and regulation of medical devices – a career spanning over 30 years.

Robert Pieper

Dr. Robert Pieper is an expert in coatings and paints for use with polymeric, rubber, and composite materials and devices.
Resources

Breaking Down the FDA’s Biosimilars Action Plan

Improving emissions performance within waste-to-heat process system

Element's team worked with our client to understand the system requirements and then proposed a number of potential designs to improve emissions performance within waste-to-heat process system.
Resources

New Dietary Ingredients (NDIs): NDI Notification Contents, Procedure & Quick Reference Guide

Resources

What You Need to Know About Amazon's Dietary Supplement Testing Requirements

Resources

ANDA Regulatory Pathway: Q1/Q2(Q3) Deformulation & Equivalence