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

Nancy Kant
Nancy Kant
Advisor
Mark Slisz
Mark Slisz
Senior Advisor
Patti Connolly
Patti Connolly
Director, Clinical Services
Robert Seevers
Robert Seevers
Senior Advisor

Biosimilar Competition Development

After the US Food and Drug Administration (FDA) released its 11-part biosimilar action plan, FDA has now announced that it will hold a public hearing to gather input “on how it can facilitate the development of biosimilars and ensure they enter the market...

New Draft Guidance on Gene Therapy

On July 11, 2018 the US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) offered 6 new draft guidance documents on human gene therapies. The documents offer a look at what it expects from an industry that is becoming...