About cGMP Consulting
WHO WE ARE
FDA Engineering and Compliance Expertise Since 2001
cGMP Consulting Inc. is an FDA compliance and engineering consulting firm, a cGMP company founded in 2001 and headquartered in Lake Forest, Illinois. We help pharmaceutical, biotechnology, medical device, OTC, dietary supplement, cosmetic, radiopharmaceutical, and other FDA-regulated organizations solve technical challenges and strengthen good manufacturing practice (GMP) compliance and quality across validation (CQV, CSV and CSA), engineering, quality, regulatory compliance, operations, and project management.
Our Story
Built on More Than Two Decades in FDA-Regulated Industries
Founded by Kevin Linde in 2001, cGMP Consulting has worked alongside hundreds of clients in highly regulated environments, to solve technical challenges, support critical projects, and strengthen quality and compliance programs.
Over the years our capabilities have expanded alongside our clients’ needs. Today we provide both specialized consulting expertise and experienced project resources across commissioning, qualification and validation; engineering; quality; regulatory compliance; operations; and project management, grounded in the frameworks that govern our clients’ work, including 21 CFR Parts 210 and 211 (pharmaceutical cGMP), 21 CFR Part 820 and the FDA Quality Management System Regulation (QMSR) for medical devices, 21 CFR Part 111 (dietary supplement cGMP), MoCRA (cosmetics), and numerous others.
Our approach remains centered on understanding each client’s specific needs and providing the right resource and level of support for the work at hand.
WHAT WE DO
Two Ways We Support Your Work
PROJECT RESOURCES
Our experienced professionals integrate directly with your team to add the technical expertise and capacity needed for facility projects, new product introductions, changing workloads, and specialized requirements, without the overhead of a permanent hire.
CONSULTING SERVICES
Our cGMP consultants provide specialized expertise to resolve quality, compliance, validation, engineering, regulatory, and operational challenges, from GMP gap assessments and audit readiness to process validation and FDA regulatory response.
OUR AREAS OF EXPERTISE
Expertise Across the cGMP Lifecycle
facilities, utilities and equipment qualification; commissioning; process and cleaning validation; and computer system validation (CSV) and computer software assurance (CSA).
facility, project, packaging, reliability and formulation engineering disciplines.
technical writing, manufacturing engineering, quality assurance and interim management.
new product introductions, quality systems, business systems and organizational change.
auditing, GMP certification readiness, FDA 483 and Warning Letter response, quality management systems, and pre-approval inspection (PAI) readiness.
Why cGMP Consulting
Experience That Extends Beyond Advice
Experienced LEADERSHIP
Chief Executive Officer & Founder
An experienced Illinois-licensed Professional Engineer with a distinguished career in the pharmaceutical industry. Kevin has built a strong track record of delivering successful projects for clients across the U.S. and internationally. He founded cGMP Consulting to turn his own industry experience into practical engineering and compliance solutions tailored to each client’s needs.
Credentials:
B.S., Chemical Engineering, University of Missouri–Columbia · Licensed Illinois Professional Engineer
Chief Operating Officer
Kate brings a proven combination of project management and subject matter expertise in pharmaceutical manufacturing, with a focus on aseptic fill-and-finish operations, validation, and operational readiness. She is an SME in facility design review against FDA regulations, quality management system (QMS) development, and radiopharmaceuticals, and recently led everything from procurement through commissioning and validation of three new filling lines. As COO, Kate oversees project delivery and the growth of the consulting team.
Credentials:
B.S., Chemical Engineering, University of Iowa
Chief Strategy Officer
With a strong understanding of cGMP Consulting’s business and clients, Sam leads strategic growth and client engagement initiatives. A project manager by background, Sam has delivered validation and project-management services for the development, installation, and qualification of automated equipment and software for pharmaceutical companies across the Chicago area, with particular depth in operational-technology security and data integrity, automated syringe filling and labeling lines, and aseptic environmental monitoring.
Credentials:
B.S., Chemical Engineering, University of Iowa
Industries We Serve
Supporting FDA-Regulated Industries
Our experience spans organizations where quality, compliance, and technical execution are critical:
Biologics & Biotechnology
Pharmaceuticals
Radiopharmaceuticals
Distributors
Cell & Gene Therapy
Medical Device
Food
2001–2026
Founded 2001 5 Core Services 11 Industries Served Hundreds of Projects Delivered 80+ Consultants
Since 2001, cGMP Consulting has built lasting relationships by providing the expertise and resources clients need to get projects done.
FREQUENTLY ASKED QUESTIONS
Careers
Build Your Career with cGMP Consulting
cGMP Consulting is always looking for talented engineers and quality and regulatory professionals who want to do meaningful work in FDA-regulated industries. We would like to hear from you. Explore our current openings and learn what it is like to be part of cGMP Consulting.
