Method Development & Validation
Reliable Method Development and Validation for Supplements, Foods, Cosmetics, and Consumer Products
Qalitex Laboratory Services, a premier ISO 17025-accredited laboratory specializing in method development and validation services. Our customized analytical methods ensure your products meet regulatory, quality, and scientific standards across a range of industries.
Whether you need new method creation, validation of existing protocols, or regulatory-ready data packages, Qalitex delivers precision, reliability, and compliance.
Why Choose Qalitex for Method Development and Method Validation?
ISO 17025 Accreditation: Ensures scientifically validated, audit-ready methodologies.
Cross-Industry Expertise: Supporting supplements, food, cosmetics, antimicrobials, and CPG products.
Regulatory Alignment: FDA, FSMA, USP, ICH, and international standards compliance.
Tailored Methodologies: Custom-designed protocols for your unique product matrix and claims.
Rapid Turnaround: Accelerated development timelines without sacrificing data integrity.
Method Development and Validation Services We Offer
Our laboratory offers complete analytical support, including:
1. New Method Development
Custom assays designed for unique formulations or challenging matrices.
Protocol creation for active ingredients, contaminants, or novel compounds.
2. Method Validation
Accuracy, precision, specificity, linearity, range, limit of detection (LOD), and limit of quantification (LOQ) studies.
Robustness and reproducibility testing.
3. Method Verification
Transfer and confirmation of previously validated methods in compliance with regulatory guidelines.
4. Method Optimization
Troubleshooting and enhancement of existing methods for improved performance and cost-effectiveness.
5. Stability-Indicating Method Validation
Analytical validation specifically targeting stability studies for shelf-life claims.
Industries We Support with Method Development and Validation
Qalitex supports method development and validation across multiple sectors:
Dietary Supplements and Nutraceuticals
Botanical and Herbal Products
Functional Foods and Beverages
Cosmetics and Personal Care Products
Antimicrobial and Sanitizer Products
Consumer Packaged Goods (CPG)
Suncare and Topical Formulations
Method Development and Validation Standards
We develop and validate methods in alignment with globally recognized standards, including:
ISO 17025 Laboratory Accreditation
FDA Guidance for Industry: Bioanalytical Method Validation
USP <1225> Validation of Compendial Procedures
ICH Q2(R1) Validation of Analytical Procedures
AOAC International Guidelines
Related Qalitex Services
Frequently Asked Questions About Method Development and Validation
Q: Why is method validation important?
A: Method validation ensures that analytical procedures produce reliable, consistent, and accurate results necessary for regulatory compliance and product quality assurance.
Q: Can Qalitex develop stability-indicating methods?
A: Yes. We specialize in developing methods that can detect product degradation and confirm shelf-life claims.
Q: How long does method development and validation take?
A: Timelines vary by complexity but generally range from 3–6 weeks for full development and validation projects.
Q: Are your validated methods accepted by Amazon, FDA, and international authorities?
A: Yes. Our ISO 17025-accredited reports meet Amazon requirements and FDA, USP, and ICH global standards.