cGMP Compliance Experts – Regulatory & Engineering Support
At cGMP Consulting, we help FDA-regulated companies meet U.S. and global compliance standards through expert current Good Manufacturing Practice (cGMP) consulting.
Since 2001, we’ve built a reputation for delivering quality-driven solutions rooted in deep technical expertise and regulatory insight.
From project engineering and validation to GMP certification and FDA inspection readiness, we provide customized support that aligns your goals with regulatory compliance. Our scalable, audit-ready solutions are designed to reduce risk, strengthen quality systems, and support successful product launches and inspections.
Our team has the knowledge, speed, and flexibility needed to effortlessly integrate with your team to deliver a strong return on investment (ROI).
Why Choose cGMP Consulting?
From large-scale validation projects of multi-million-dollar facilities to developing quality management systems in a one-person company, we provide end-to-end services tailored to your business and industry.
Our seasoned professionals bring deep expertise and problem-solving ability to every project. We offer scalable bandwidth, meeting your compliance and business objectives.
We adapt to your needs; our staff is available onsite or remote. Your compliance is our commitment to a project done right and on schedule.
We streamline compliance and engineering processes, optimizing costs and reducing risks. Our smart solutions save you time and resources — we’re your competitive advantage.
Let cGMP Consulting be your trusted partner in compliance and operational success.
Our Core Services
With more than 75 engineers and consultants, cGMP Consulting offers services in the following areas:
Industries We Serve
We help companies across a variety of regulated industries achieve cGMP compliance and operational excellence.
Biologics & Biotechnology
Pharmaceuticals
Radiopharmaceuticals
Distributors
Cell & Gene Therapy
Medical Device
Food
Our Clients
In over 20 years, we’ve successfully completed thousands of projects for hundreds of clients, with the majority returning to partner with us again—a clear reflection of their trust and satisfaction in our services.
case study
Supporting a $350 million pharmaceutical facility expansion:
We played a pivotal role in a major pharmaceutical manufacturing expansion, supporting the project from initial building design through full validation and operational readiness. Our involvement included:
- Engineering Design: User Requirements Specifications (URS) and Risk Assessments (RA)
- Procurement Support: Request for Proposals (RFPs) and Purchase Orders (POs)
- Compliance Oversight: Ensuring adherence to regulations during engineering delivery
- Qualification & Validation: Execution of FAT, SAT, IQ, OQ, and PQ protocols
Our expert team provided full-spectrum support, including Project Management, Commissioning, Qualification and Validation, Engineering Services, and specialized roles such as microbial sampling, calibration, and maintenance coordination.
At the project’s peak, we had 48 staff members onsite, scaling as needed to meet the client’s evolving demands.
Trending News
Understand 21 CFR Part 111, the cGMP dietary supplement regulations for safe and compliant supplement manufacturing.
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It’s Easy to Partner with Us
It’s Easy to Partner with Us
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Response
Receive a response in 1-3 business days
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Meet with our Experts
Discuss your challenges and goals
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Proposal
Receive a customized roadmap for cGMP compliance success
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Project Kickoff
Begin implementing solutions with our team
Client Testimonials
“cGMP Consulting understands our needs and their employees’ experience. I can explain the project expectations, they understand, and we are not disappointed with the results.”
“Time is precious so to have someone familiar with our processes and resources is quite valuable and hard to find. cGMP Consulting provides immediate help.”
“Working with cGMP Consulting is economical. Their rate charging is ideal because of low overhead. cGMP being a small company is an advantage.”
“cGMP Consulting is a good value. They are flexible and are willing to cover nights and weekends to meet project deadlines. This is a hard to find in a consulting firm. The level of quality is just different.”
