Life Science Accelerated

Pearl Pathways is a comprehensive life sciences professional services company. Our experienced team is dedicated to expediting life science product development pathways.

Product Development Experts

Pearl Pathways partners with your clinical and regulatory experts, quality and auditing teams, and senior leadership to accelerate development of life saving therapeutics, devices, diagnostics.


We understand the regulatory burdens imposed upon drugs and biologics. Our nimble team advances both early stage pre-commercialization companies and multinational organizations through these challenging regulatory hurdles.

Medical Devices

Our flexibility allows us to support simple to high-risk, complex implantable devices. We support the development, validation, design and regulatory submission of your device with the appropriate regulatory body.


Diagnostics are different. Our services manage the entire diagnostic development cycle, from target selection to global product launch and beyond. Our vast expertise allows us to broadly serve IVD, implantables, imaging, software, and companion diagnostics.

Service Providers

We strategically partner with CROs, CMOs, laboratories, research sites, and others to provide timely solutions. We understand the pressure of meeting your clients’ needs, and our responsive team builds strong relationships to help our partners win.

We wouldn’t be where we are today without Pearl Pathways. Their advisors’ expertise and flexibility helps keep us on track to overcome obstacles and meet deadlines. They have been there with us through the various ups and downs of our pharma startup.

CEO and Founder, Startup biopharma company

March 2017

Top Talent

John Lockwood
John Lockwood
RAC, CQA, CSQE - Senior Advisor
Shawn Knopp
Shawn Knopp
PhD - Advisor
Gretchen Parker
Gretchen Parker
PhD, RAC, CIP - Co-Chair & Board Member
Patti Hunker
Patti Hunker
MS, ATC, CCRC - Clinical Research Advisor

CBER, CDER issue data standards strategy through 2022

The Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) released the data standards strategy for 2018-2022 on Monday. The purpose of the CBER-CDER Data Standards Strategy is to reinforce the ongoing...