cGMP Consulting Inc.

Your cGMP Compliance and Engineering Partner

About the firm

cGMP Consulting Inc. provides engineering and regulatory compliance services to FDA-regulated industries. Operating since 2001, it offers customized support that aligns client goals with regulatory compliance, spanning project engineering, validation, GMP certification, and FDA inspection readiness. Its scalable, audit-ready solutions are designed to reduce risk, strengthen quality systems, and support successful product launches and inspections.

Established: 2001
Team: Midsize
Firm type: Automation & Controls · Process Engineering

Credentials

ISO Accredited

Capabilities

Commissioning, Qualification, and Validation (CQV)

Service website

Ensures facilities, systems, utilities, and equipment operate in compliance with FDA and global regulatory standards.

Commissioning
Facilities, Utilities, and Equipment Qualification
Cleaning Validation
Process Validation
Product Performance Qualification
Computer System Validation
GMP Warehouse Qualification and Compliance

Quality and Regulatory Compliance

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Establishes, audits, and maintains robust quality management systems to align operations with international cGMP expectations.

Auditing
Quality Management System Development
GMP Certification
483/Warning Letter Assistance
MoCRA Compliance
Training

Project and Operations Support

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Delivers cross-functional oversight, engineering resources, and strategic execution to support manufacturing operations and operational readiness.

Engineering Support
Operations Support
Project Management
New Product Introductions

Business Systems and Processes

Service website

Implements computerized business platforms and electronic document management systems to drive efficiency and traceability.

Business System Implementation
Electronic Document Management Systems (EDMS)
Business Process Change Management

Industries

Consumer Products · Food & Beverage · Life Sciences · Medical Devices · Pharmaceutical

Projects

Pharmaceutical Facility Expansion

Pharmaceutical

Project details

Supported a major 350 million dollar pharmaceutical manufacturing expansion from initial building design through full validation and operational readiness. Activities included engineering design (URS and Risk Assessments), procurement support (RFPs and POs), compliance oversight, and the execution of FAT, SAT, IQ, OQ, and PQ protocols. Provided up to 48 onsite staff members for project management, commissioning, qualification, validation, engineering, microbial sampling, calibration, and maintenance coordination.