Method Development & Validation

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

• Chemistry Testing Services

• Microbiology Testing Services

• Shelf-Life and Stability Testing

• Regulatory and Label Compliance Consulting

• Dietary Supplement and Nutraceutical Testing

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.