Pearl Pathways Hires Shawn Knopp


Experienced biopharma and medical device leader joins Pearl Pathways

INDIANAPOLIS, INDIANA –December 1, 2016 — Pearl Pathways is pleased to announce the hiring of Shawn Knopp, PhD as an Advisor serving medical device and biopharmaceutical life science companies. Knopp brings to Pearl Pathways over 15 years of experience in multi-disciplinary life science roles including project management, product development, regulatory, engineering, and manufacturing.
Knopp’s extensive leadership positions in Product Development, Technical Operations, and Project Management at top industry companies including Pfizer, Johnson and Johnson, Baxter Healthcare, Zimmer Biomet, and GSK allow him to expertly meet clients’ needs in a number of key areas including quality systems, process improvement, regulatory submissions, IT implementations, supply chain, and manufacturing strategy.

Knopp provides senior project management oversight for complex regulatory and quality consulting projects for Pearl Pathways’ clients. He develops regulatory strategies for global submissions and leads functional teams across clinical, non-clinical, device engineering, CMC, quality, etc. in gathering and authoring required information for regulated systems and submissions.

Knopp earned his Bachelor of Science in Chemical Engineering at the University of Louisville, a PhD in Industrial Pharmacy/Pharmaceutics from Purdue University, and an MBA at Elon University.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Shawn’s extensive leadership experience navigating a variety of regulatory compliance challenges in large multi-nationals and small startups. He brings to our team expert technical knowledge of developing regulatory strategies, quality systems, and manufacturing capabilities. His past experience working as in independent consultant in the industry allows him to adapt to the dynamic needs of the biopharmaceutical and medical device companies we serve. We are so pleased to welcome Shawn to the team.”

About Pearl Pathways
Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:

Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.

Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.

Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at, call us at (317) 899-9341, or email Pearl Pathwaysis located in Indianapolis, Indiana, and isAAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact