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

REGULATORY

Regulatory Strategy & Filings
eCTD
Toxicology

QUALITY COMPLIANCE

GXP Quality Systems
Auditing
CMC Development & Supplier Management

CLINICAL & CRO SERVICES

Niche CRO
Medical Writing
GCP Support Services

INDEPENDENT REVIEW BOARD

IRB Board Review Services
Patient Recruitment Materials and Ads
IRB Exemption Determination

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

Truly my experience with your regulatory expertise has been the best I have come across. Every consultant is willing to “pontificate” but few (in my experience) are willing to get in and actually read, think and do the hands on work that you know will be thorough and reliable….you have been light years beyond others I have worked with. I hope my references come to you.

Pharmaceutical Quality/Compliance Consultant

[We] were discussing how refreshing it is to watch well experienced regulatory professionals collaborate with one another, and… proactively apply creative approaches to our entire program. I know we have a long way to go, but we can’t thank you enough!

Regulatory Advisor & Director of Program Management, Startup biotech company

Our Experienced Team

Robert Seevers, PhD, CBA
Robert Seevers, PhD, CBA
Consultant Advisor, Former FDA Reviewer
Gretchen Miller Bowker, MS, RAC, FRAPS
Gretchen Miller Bowker, MS, RAC, FRAPS
Chief Executive Officer
Patti Hunker, MS, CCRC, CCRA
Patti Hunker, MS, CCRC, CCRA
Director of Clinical Services
Gretchen Parker, PhD, RAC, CIP
Gretchen Parker, PhD, RAC, CIP
IRB Co-chair & Board Member, Senior Advisor
Heidi Unger
Heidi Unger
Senior Analyst, RA/QA
Eric English, MS, CBA, RAC
Eric English, MS, CBA, RAC
Director, RA/QA Services

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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.