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.
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.
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
The United States Food and Drug Administration (FDA) released a new draft guidance as part of its stated commitment to assist sponsors and expedite drug development for rare pediatric diseases, Outsourcing-Pharma.com reports. FDA collaborated with the...
European notified bodies currently face significant stress on their resources and expertise. Completing assessments of the device component of higher-risk drug/device combination products is proving to be a significant challenge for the EU as it enters the...
The Power of LinkedIn for Life Science Professionals – Diana Caldwell to deliver presentation at Purdue Foundry
Join Diana Caldwell, President and CEO of Pearl Pathways, this Friday, December 1, 2017 at Purdue Foundry as she discusses "The Power of LinkedIn for Life Science Professionals." Foundry Grounds occurs each Friday and involves conversations,...