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GMP Testing Services

Don’t Let Testing Gaps Delay Approvals or Risk Compliance

At Quantum Analytics Group, we deliver Good Manufacturing Practice (GMP)-compliant testing that safeguards the quality, safety, and regulatory readiness of your products. Our laboratories generate precise, defensible results for APIs, drug products, and drug–device combination products across all phases of development. From early-stage studies through full-scale commercialization, we provide both CMC analytical expertise and GMP testing to support your program. With experience spanning Phase I, II, and III trials and beyond, our team delivers the clarity and reliability you need to achieve compliance with global regulatory expectations — including FDA, ICH, EP, and USP requirements — ensuring a smooth path to market approval.
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From Use Cases to Results: The Role of GMP Testing

Define Testing Requirements
Identify the product, material, or process that needs GMP validation and outline the regulatory standards it must meet.

Select Appropriate Methods
Choose from validated compendial methods or develop customized assays tailored to the product’s needs.

Perform GMP-Compliant Testing
Carry out testing with strict controls to ensure accuracy, consistency, and regulatory alignment.

Deliver Defensible Results
Provide clear reports with compliance-ready documentation to support audits, approvals, and ongoing quality assurance.

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Regulatory Submissions and Approvals
GMP testing supports method validation, stability studies, and release testing that provide the defensible data required by FDA, EMA, and other global agencies.

Batch Release and Quality Control
Before a drug product can reach the market, GMP testing verifies identity, purity, strength, and consistency to ensure every lot meets specifications.

Manufacturing Investigations and Troubleshooting
When contamination, variability, or unexpected results appear during production, GMP testing helps trace the source, resolve issues, and prevent future failures.

 

 


 

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We're Not Just a Lab, We're a Testing Partner You Can Rely On

Built for Regulated Industries

30 years of solving complex product and compliance challenges

Real People. Real Answers.

Work directly with scientists who guide you, not just test for you.

Testing That Goes Deeper

We don’t just test — we troubleshoot, explain, and guide.

Ready to Get Results You Can Trust?

Book a consult with our team to discuss your goals, get expert input, and map out your next steps — with no pressure, just clarity.

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