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.

Biopharma

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

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

Former FDA regulatory scientist joins Pearl Pathways

Pearl Pathways is proud to announce the hiring of Robert Seevers, PhD as Senior Advisor. Seevers brings over 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold...

What is an FDA guidance document?

This is the first in a series of blog entries about U.S. Food and Drug Administration (FDA) guidance documents. As it happens, FDA has published a number of draft and final guidances in the past few months. We will provide an in-depth analysis of a few...