Compliance, Registrations, Audits & Training
Our Mission
Our Mission
Our Mission
At GAP Regulatory Consulting, we help life sciences companies navigate the gap between innovation and regulation. With expertise in establishment registration, drug product listing, WDD licensing, and other critical compliance processes, we provide clear, experienced guidance to move our clients forward with confidence.
Our Team
Our Mission
Our Mission
At GAP Regulatory Consulting, our team combines experience, precision, and a straightforward approach to regulatory work. Clients appreciate that we are easy to work with, responsive, and thorough—especially when navigating establishment registration, drug product listing, and WDD licensing. As a family-run business, we bring a level of trust and communication that strengthens every partnership.
Our Promise
Our Mission
Our Promise
We promise to serve our clients with professionalism, clarity, and consistency. From initial consultation through completion, we provide timely, straightforward communication while guiding you through establishment registration, drug product listing, WDD licensing, and other regulatory requirements. Our goal is to ensure every project is handled with care, accuracy, and confidence.
About Us - Regulatory Consulting Services
L.J. Anderson, MA
Stephen L. Pruitt, MS
L.J. Anderson, MA
Consultant, LJ Anderson has 25 years of experience in editing, designing, researching markets, and managing robust schedules, particularly in the field of pharmaceutical consulting. With two decades dedicated to professional writing across multi-media platforms, she has worked with various business models, from the garment industry to data mining, and has navigated every life sciences hallway in between. Her exceptional communication skills with federal and state offices, especially regarding FDA compliance and regulatory affairs, are unmatched.
LJ has completed thousands of professional edits and detailed processes, is a published author, holds an MA from the Stan Richards School of Advertising and Public Relations, and is a proud member of the Regulatory Affairs Professional Society (RAPS).
Glenn A. Pruitt
Stephen L. Pruitt, MS
L.J. Anderson, MA
Founder and consultant, Glenn Pruitt, brings over 35 years of experience in pharmaceutical consulting, specializing in pharmaceutical regulatory affairs and HR. Previously the Executive Vice President of Regulatory at Cypress Pharmaceuticals, he has aimed to establish a one-stop shop for companies seeking assistance with everything from general company startup to achieving FDA compliance and adhering to specific industry standards.
With four decades in the pharmaceuticals sector, he boasts a track record of 100% inspection compliance and has conducted over 400 audits to date, covering raw materials, manufacturers, WDDs, test labs, repackagers, and 3PLs. Glenn is also a proud member of the Regulatory Affairs Professional Society (RAPS).
Stephen L. Pruitt, MS
Stephen L. Pruitt, MS
Stephen L. Pruitt, MS
Consultant Stephen Pruitt brings 15 years of experience in quality and regulatory affairs across aerospace and life sciences, specializing in FDA compliance. He has directed his combat-tested expertise in managing personnel, assets, and supply chains, following in his father's footsteps to enhance relations between stakeholders and regulatory bodies concerning foods, drugs, cosmetics, and devices. His background includes 5 years in federal service and 10 years in business ownership, where he has provided valuable pharmaceutical consulting. He has received the Air Force Outstanding Unit Award and served as Officer in Charge. Stephen holds an MS in Health Promotion and is a member of the Regulatory Affairs Professional Society (RAPS).