Heavy Metal Testing for Regulatory submission
Reliable heavy metal testing designed for regulatory submission. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025
Resultados en 48 h
100 % garantía
Respuesta rápida
Heavy Metal 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.
FDA Warns of Elevated Lead Levels in Dietary Supplement Products
The FDA issued safety warnings after detecting elevated lead concentrations in multiple supplement brands sold online, underscoring the need for independent third-party heavy metal testing before launch.
Achieving regulatory submission requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides heavy metal testing tailored for regulatory submission requirements. Our state-of-the-art laboratory specializes in accurate, regulatory-compliant heavy metals testing for dietary supplements, food products, and cosmetic formulations. Our advanced ICP-MS methodologies, experienced chemists, and FDA-audited protocols ensure your products meet the highest safety and quality standards. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your regulatory submission process.
How Heavy Metal 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.
Why Heavy Metals Testing Is Critical
Heavy metals like arsenic, lead, cadmium, and mercury are toxic even at low concentrations. They can contaminate ingredients through soil, water, processing equipment, and packaging. Regulatory bodies require strict compliance with heavy metal limits to prevent neurotoxicity, kidney damage, developmental delays, and carcinogenicity.
Metals We Test For
We test for all commonly regulated metals: Lead (Pb), Cadmium (Cd), Arsenic (As — total and inorganic), Mercury (Hg — total and methylmercury), Nickel (Ni), Chromium (Cr), Tin (Sn), Cobalt (Co), Antimony (Sb), Thallium (Tl), Copper (Cu), and Zinc (Zn). Custom panels and additional trace metal screening available on request.
ICP-MS Technology
Our laboratory uses ICP-MS (Inductively Coupled Plasma Mass Spectrometry) — the gold standard for multi-element trace detection at parts-per-billion (ppb) sensitivity. This enables reliable, reproducible results at concentrations far below regulatory limits.
Ensayos y métodos clave
Normas aplicables
Sectores que atendemos
Cómo funciona
Tres sencillos pasos hasta sus resultados
Envíe sus muestras
Envíe las muestras a nuestro laboratorio de Irvine o San Diego junto con su formulario de pedido.
Análisis y resultados
Nuestros científicos acreditados según ISO 17025 aplican métodos de ensayo validados.
Reciba su CoA
Obtenga un certificado de análisis firmado en 48–72 horas.
Preguntas frecuentes
Preguntas frecuentes
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 heavy metals does Qalitex test for?
Qalitex tests for lead (Pb), cadmium (Cd), arsenic (As — total and inorganic), mercury (Hg), nickel, chromium, tin, cobalt, antimony, thallium, copper, and zinc using ICP-MS instrumentation with parts-per-billion sensitivity.
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