Life Science Accelerated
Pearl Pathways is a comprehensive life sciences professional services company. Our experienced team partners with your clinical and regulatory experts, quality and auditing teams, and senior leadership to accelerate development of life saving therapeutics, devices, diagnostics.
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Services to Accelerate Your Therapeutics, Devices, or 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.
Product Development Experts
INDEPENDENT REVIEW BOARD
IRB Board Review Services
Patient Recruitment Materials and Ads
IRB Exemption Determination
Our Experienced Team
Latest News From Our Blog
Feasibility: Help or Hinderance in Clinical Trial Start-up?
The site feasibility process has been a source of angst among Sponsors/CROs and sites for years....
Proposed Legislation Aims to Expand FDA’s DTC Toolkit
Last February, Senate leaders addressed FDA Commissioner Robert Califf, M.D. asking the Agency to...
Implications of FDA’s New Rule on Laboratory-Developed Tests (LDTs) for Clinical Laboratories
On April 29, 2024, FDA introduced a significant regulatory shift affecting the landscape of...
Call For A 30 Minute Consultation
Partner with Pearl Pathways for your clinical and regulatory experts, quality and auditing teams, and senior leadership to accelerate development of life saving therapeutics, devices, diagnostics.