Certificate of Analysis for Regulatory submission
Reliable certificate of analysis designed for regulatory submission. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
48 小时出结果 
100% 保证 
快速解答
Certificate of Analysis 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.
Amazon Tightens COA Requirements for Supplement and Cosmetic Sellers
Amazon sellers face increased scrutiny as the platform mandates ISO 17025 accredited COA documentation for health and beauty products — with non-compliant listings facing immediate suspension.
Achieving regulatory submission requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides certificate of analysis tailored for regulatory submission requirements. A Certificate of Analysis (CoA) is your product's credential for market access. Qalitex Laboratories provides ISO 17025 accredited CoAs for all test types — identity, potency, heavy metals, microbiology, pesticide residues, and stability. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your regulatory submission process.
How Certificate of Analysis 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 a CoA Includes
Every Qalitex CoA includes: product description and batch number, test methods (USP, AOAC, ISO), results with specification limits, accreditation number and lab credentials, scientist signature and date, and chain of custody documentation. Reports are delivered in PDF format suitable for Amazon Seller Central, retailer portals, and regulatory submissions.
When You Need a CoA
You need a CoA for Amazon FBA supplement listings, retail compliance (Whole Foods, Target, Vitamin Shoppe), import/export documentation, FDA facility inspections, brand protection and labeling accuracy, and third-party quality audits.
Our Turnaround Time
Standard CoA delivery is 48–72 hours from sample receipt. Rush options are available for time-sensitive listings or compliance deadlines. We serve clients across all 50 US states from our Irvine, California laboratory.
主要检测项目与方法
适用标准
服务行业
检测流程
三个简单步骤获取结果
提交样品
将样品连同订单表格寄送至我们的尔湾或圣地亚哥实验室。
检测与分析
我们的 ISO 17025 认证科学家使用经过验证的检测方法进行分析。
收取 CoA 报告
在 48–72 小时内获得签名的合格证书。
常见问题
常见问题解答
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 included in a Certificate of Analysis (CoA)?
Every Qalitex CoA includes product description and batch number, test methods (USP, AOAC, ISO), results with specification limits, accreditation number and lab credentials, scientist signature and date, and chain of custody documentation.
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