cGMP Consulting

cGMP Consulting Inc. provides engineering and regulatory compliance services tailored to FDA-regulated industries. Specializing in current Good Manufacturing Practice (cGMP) consulting, the firm helps companies navigate U.S. and global compliance standards. With over 25 years of experience, cGMP Consulting delivers quality-driven solutions based on deep technical and regulatory expertise.

The firm offers a range of services:

• Project Engineering and Validation: Support from initial design to full validation and operational readiness.
• GMP Certification and Inspection Readiness: Customized solutions to align goals with compliance, reducing risks and strengthening quality systems.
• Compliance Oversight: Ensures adherence to regulations during engineering delivery.
• Qualification & Validation: Execution of FAT, SAT, IQ, OQ, and PQ protocols.

cGMP Consulting serves a wide array of industries, including biologics, biotechnology, pharmaceuticals, radiopharmaceuticals, cell and gene therapy, medical devices, and food. The team, consisting of over 75 engineers and consultants, is equipped to handle both large-scale projects and smaller operations, providing scalable and audit-ready solutions.

The firm's approach is characterized by its ability to integrate seamlessly with client teams, offering both onsite and remote support. This adaptability allows them to meet compliance and business objectives efficiently. By optimizing costs and reducing risks, cGMP Consulting positions itself as a competitive advantage for its clients.