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The regulatory landscape is constantly shifting. We provide the technical insights and regulatory updates you need to keep your products compliant and your patients safe.
Technical White Papers.
Frequently Asked Questions.
How do you handle Out-of-Specification (OOS) results?
We view an OOS as a critical investigation, not just a data point. We follow a rigorous Phase I / Phase II investigation protocol to determine the root cause—whether it is laboratory error or a true process failure. We work collaboratively with your Quality Unit to close investigations rapidly.
What is your standard Turnaround Time (TAT)?
In pharma, accuracy is the only metric that matters. While standard release testing typically takes 5–7 business days, our promise is On-Time Delivery. We agree on a due date at sample receipt, and we hit it. RUSH services are available upon request.
Can we audit your facility?
Absolutely. Transparency is our policy. We welcome both virtual and on-site audits. Contact our Quality Assurance team to schedule a tour of our 8,000 sq. ft. facility and review our QMS.
Do you handle Method Transfers?
Yes. We strictly follow USP <1224> Transfer of Analytical Procedures. We can accept validated methods from your current lab or perform a co-validation to ensure seamless continuity of your testing program.
What specific instrumentation do you use for heavy metals?
A: We utilize the Agilent 7850 ICP-MS with prepFast 4 DXCi. This allows us to achieve the ultra-low detection limits required for USP <232> compliance with superior throughput and precision.
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