Stability Testing for Regulatory submission
Reliable stability testing designed for regulatory submission. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
Quick Answer
Stability Testing for regulatory submission ensures products meet the specific regulatory and quality standards required for market entry. ISO 17025 accredited laboratories like Qalitex provide validated testing methods, detailed COA reports, and expert guidance to support regulatory submission processes efficiently.
Achieving regulatory submission requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides stability testing tailored for regulatory submission requirements. Qalitex Laboratories specializes in dietary supplement stability testing that ensures your products remain safe, potent, and effective throughout their intended shelf life. Our testing services comply with FDA regulations, follow GMP standards, and support your product's market longevity. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your regulatory submission process.
How Stability Testing Supports Regulatory submission
Regulatory submission requires documented evidence of product safety and quality. Qalitex provides the specific testing and documentation needed to support your regulatory submission process, including detailed COA reports, method validation documentation, and expert consultation on testing scope. Our ISO 17025 accreditation ensures your results are accepted by regulatory bodies and marketplace platforms.
What Is Stability Testing and Why It Matters
Stability testing evaluates how a dietary supplement performs under various environmental conditions — temperature, humidity, and light. We conduct both real-time and accelerated stability studies per ICH Q1A(R2) guidelines, assessing active ingredient potency, microbiological integrity, packaging durability, and organoleptic properties (color, odor, texture).
Shelf Life Testing
Shelf life testing defines how long a supplement remains both safe and effective, providing the data needed for accurate expiration dating. We simulate extended storage under real and accelerated conditions, testing at 0, 1, 3, 6, and 12 months, evaluating degradation of actives and risk of microbial growth.
Our Testing Process
We test a wide range of formats: tablets, capsules, softgels, powders, gummies, and liquids. Every study includes a protocol design phase, appropriate chamber conditions (ICH Zone I–IV), testing intervals, and a final stability report with CoA documentation suitable for FDA submission.
Key Tests & Methods
Applicable Standards
Industries We Serve
How It Works
Three simple steps to your results
Submit your samples
Ship samples to our Irvine or San Diego laboratory with your order form.
Testing & analysis
Our ISO 17025 accredited scientists run validated test methods.
Receive your CoA
Get a signed Certificate of Analysis within 48–72 hours.
FAQ
Frequently Asked Questions
What testing is required for regulatory submission?
Regulatory submission typically requires identity testing, purity analysis, potency verification, and contaminant screening. The exact panel depends on your product type and target market. Qalitex Labs can recommend the appropriate testing scope for your specific regulatory submission needs.
How long does testing take for regulatory submission?
Standard turnaround at Qalitex is 5–7 business days, with rush 48-hour service available for most test types. We recommend planning testing 2–3 weeks ahead of your regulatory submission deadline to allow for any retesting if needed.
Is Qalitex Laboratories ISO 17025 accredited?
Yes. Qalitex Laboratories holds ISO/IEC 17025 accreditation, the international standard for testing and calibration laboratories. This ensures our methods, equipment, and quality systems meet the highest standards of accuracy and reliability.
What is your turnaround time?
Standard turnaround is 5–7 business days. Rush service with 48-hour turnaround is available for most test types. Contact us to discuss your timeline requirements.
What types of products do you test?
Qalitex tests dietary supplements (capsules, powders, gummies, liquids), cosmetics and personal care products, food and beverage items, botanical extracts, and raw materials. We serve brands, contract manufacturers, and Amazon FBA sellers.
How do I submit samples for testing?
Ship your samples to our Irvine or San Diego laboratory with a completed sample submission form. We provide prepaid shipping labels for qualifying orders. Results are delivered electronically via secure portal.
What is the difference between real-time and accelerated stability testing?
Real-time stability testing stores products under normal conditions and tests at intervals over months or years, while accelerated stability testing uses elevated temperature and humidity to predict shelf life faster. Qalitex performs both types per ICH Q1A(R2) guidelines.
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Ready to get started?
Request a quote for stability testing supplements for regulatory submission. Our team responds within 24 hours.