Antimicrobial Testing for Regulatory submission
Reliable antimicrobial testing designed for regulatory submission. ISO 17025 accredited methods with detailed reporting to meet your regulatory requirements.
ISO 17025 
نتائج خلال 48 ساعة 
ضمان 100% 
إجابة سريعة
Antimicrobial 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 Issues Guidance on Antimicrobial Efficacy Claims for Personal Care Products
New FDA guidance requires substantiation for antimicrobial and antibacterial efficacy claims in personal care products, requiring validated in vitro testing from accredited laboratories.
Achieving regulatory submission requires accurate, accredited laboratory testing that regulatory bodies and marketplace platforms trust. Qalitex Laboratories provides antimicrobial testing tailored for regulatory submission requirements. Antimicrobial testing evaluates a product's ability to inhibit or kill microbial organisms. Qalitex Laboratories provides validated antimicrobial activity tests for natural ingredient brands, cosmetic preservative systems, and supplement products making antimicrobial claims. Our ISO 17025 accredited methods and detailed COA reports are designed to streamline your regulatory submission process.
How Antimicrobial 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.
Minimum Inhibitory Concentration (MIC)
MIC testing determines the lowest concentration of a substance that inhibits visible growth of a microorganism after overnight incubation. We test against a panel of standard organisms including S. aureus, E. coli, P. aeruginosa, and C. albicans.
Minimum Bactericidal Concentration (MBC)
The MBC is the lowest concentration that kills ≥99.9% of the initial inoculum. MBC data is required for products making bactericidal claims and for natural preservative systems in cosmetics.
Preservative Efficacy (Antimicrobial Effectiveness Testing)
Per USP <51> and ISO 11930, we perform challenge testing to evaluate whether a cosmetic or pharmaceutical preservative system maintains product safety throughout its shelf life and during consumer use.
الاختبارات والأساليب الرئيسية
المعايير المعمول بها
القطاعات التي نخدمها
كيف يعمل
ثلاث خطوات بسيطة للحصول على نتائجك
أرسل عيناتك
أرسل العينات إلى مختبرنا في إيرفاين أو سان دييغو مع نموذج الطلب.
الاختبار والتحليل
يطبق علماؤنا المعتمدون بـ ISO 17025 مناهج الاختبار المعتمدة.
استلام CoA
احصل على شهادة تحليل موقعة خلال 48–72 ساعة.
الأسئلة الشائعة
الأسئلة الشائعة
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 MIC testing?
Minimum Inhibitory Concentration (MIC) testing determines the lowest concentration of a substance that inhibits visible growth of a microorganism after overnight incubation. Qalitex tests against standard organisms including S. aureus, E. coli, P. aeruginosa, and C. albicans.
خدمات الاختبار ذات الصلة
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اطلب عرض سعر لـ antimicrobial testing for regulatory submission. يرد فريقنا خلال 24 ساعة.