Testing Compliance

Every Test, at the Right Point in the Process

This includes raw material testing, in-process testing, finished product testing, and stability studies. We verify that the right tests happen at the right points, that methods are scientifically valid for their purpose, and that the paperwork behind every result would satisfy the person most likely to read it: an FDA investigator or a third-party auditor.

• Raw material, in-process, and finished product testing review
• Stability study protocol verification
• Lab documentation and method validation audit
• Protocol redesign and lab staff retraining

Built on Real Lab Experience

Our consultants have worked in microbiological and analytical chemistry laboratories, so we review your testing program from the bench, not from a checklist. Testing gaps discovered here often feed a broader GMP gap assessment, and serious findings can be closed through our GMP remediation programs.

Common Questions

What testing does FDA expect for our products?

It depends on your product type and the applicable regulation, such as 21 CFR Part 111 for dietary supplements or Parts 210 and 211 for drugs. We map the requirements that apply to your specific products and verify your protocols against them.

Do you work with third-party labs?

Yes. We help you qualify contract laboratories, review their methods and certificates of analysis, and make sure their testing satisfies the requirements your products carry.

Can you fix documentation gaps in our lab records?

Yes. We audit your records and data practices, redesign protocols where needed, and retrain lab staff so results hold up under regulatory scrutiny.