Ensuring the safety, quality, identity, potency, and purity of your pharmaceutical products
Establishing a new facility
Upgrading equipment
Launching a new product line
We bring decades of experience with state-of-the-art pharmaceutical manufacturing to help you first achieve and then maintain compliance with global regulations and standards.
At cGMP Consulting, we pride ourselves on a proven track record of gold-standard CQV. Our services are customized to meet the unique needs of pharmaceutical, biotech, and medical device companies, as well as other FDA-regulated industries with varying compliance requirements.
Our team brings a hands-on approach, supporting a wide range of projects, from facility expansions and utility upgrades to complete packaging line installations and periodic validations. We are involved every step of the way, taking the lead to ensure a successful project delivery.
We ensure your capital projects not only meet regulatory standards but also achieve peak operational efficiency, setting the stage for reliable and reproducible product quality.
Our CQV Services
Our Facilities, Utilities, Equipment Qualification (FUE) delivers thorough validation to assure compliance with cGMP and other regulatory requirements, ensuring consistent performance and reliable operations.
Our comprehensive Commissioning process meticulously verifies and documents that your systems, equipment, and utilities are designed, installed, and operationally ready, establishing a solid foundation for qualification and production.
Our experienced Project Management team coordinates and oversees CQV projects, ensuring timely execution, compliance adherence, and operational efficiency.
Our thorough Cleaning Validation confirms your cleaning procedures effectively remove residues and contaminants, safeguarding product integrity and preventing cross-contamination.
Our Process Validation ensures manufacturing processes reliably produce high-quality products consistently, meeting FDA and global pharmaceutical standards.
Our Product Performance Qualification confirms your products meet predefined specifications, regulatory standards, and quality requirements, ensuring readiness for successful market entry.
Our Computer System Validation provides comprehensive testing and documentation, ensuring computerized systems operate securely, reliably, and fully compliant with regulatory standards.
Our Electronic Document Management System service helps through system selection, migration, validation, training, and support to make your document control simple and compliant.
Our Proven Approach
At cGMP Consulting, we utilize a risk-based approach, focusing on critical systems that impact product quality and patient safety. Our highly experienced team works closely with your in-house staff to streamline the CQV process, minimize downtime, and ensure that all documentation is audit-ready and compliant.
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Gap Analysis & Risk Assessments
Our Gap Analysis and Risk Assessments rigorously evaluate your systems to pinpoint compliance gaps, prioritizing critical systems impacting quality and regulatory compliance.
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Tailored Documentation & Protocols
We develop customized protocols and procedures that fit the specific needs of your facility, ensuring that all steps are thoroughly documented and traceable.
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On-Site Support & Training
Our team is available for on-site support to oversee the implementation of CQV activities. We also offer training to ensure your staff is fully equipped to maintain validated systems and processes.
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.
Why Choose cGMP Consulting?
Get Started with cGMP Consulting
Whether you’re starting a new project or need support maintaining compliance in an existing facility, cGMP Consulting is here to help. Contact us today to learn more about how our Commissioning, Qualification, and Validation services can support your business.
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