Method Development & Validation Services for Complex Formulations
When your product doesn’t fit within standard testing protocols, you need a method built for it. At Ayah Labs, we design and validate custom analytical procedures for supplements, botanicals, and personal care products. Built to deliver accuracy, reproducibility, and compliance with FDA, GMP, and ISO expectations.
Why Method Development and Validation Matters
Validated methods are the foundation of reliable testing. Without them, you risk inaccurate results, failed audits, or rejected product claims, especially when launching novel formats or entering new markets.
Ensure your test method fits your formulation
Botanicals, emulsions, oils, and powders all behave differently. We develop analytical procedures that work with your product’s matrix, not against it.
Meet FDA, USP, and GMP documentation requirements
Method validation is required under 21 CFR Part 111, USP <1225>, and other global frameworks. We provide the protocols and performance data you need to comply.
Support product claims and batch release
Whether you’re quantifying an active or confirming purity, validated methods ensure your data stands up during quality reviews, audits, and Amazon listing reviews.
Avoid false results from unoptimized methods
Unvalidated methods can lead to inaccurate potency, false positives for contaminants, or overlooked degradation, putting your brand and customers at risk.
Build trust in new or novel product types
From adaptogen blends to microbiome skincare, innovative products require tailored methods. We help you generate data that’s credible, consistent, and publication-ready.
What Our Process Includes
Every method we develop is tailored to your product, analyte, and regulatory target. We apply a structured approach grounded in internationally recognized best practices.
Analytical platform selection (HPLC, GC, UV-Vis, etc.)
We choose the most appropriate technology for your analyte and matrix, ensuring sensitivity and specificity.
Sample preparation optimization
From solvents to dilutions to filtration steps, we refine the process to minimize interference and improve reproducibility.
Linearity, accuracy, and detection limits
We assess the method’s performance across your product’s expected range, ensuring precision, low-level detection, and traceable results.
Robustness and specificity testing
We stress the method under varied conditions to confirm it still performs, accounting for small changes in conditions, instruments, or analysts.
Formal validation report with method traceability
You receive a full report outlining all parameters, results, and justifications, suitable for regulatory submission, method transfer, or quality audits.
Who Needs Method Development Services
If you’re working outside the norm, method development is essential. Our clients include innovators, global brands, and private labelers who need more than an off-the-shelf testing solution.
- Supplement companies using novel botanicals
- Skincare and personal care brands with unique actives
- Formulations with complex or interfering matrices
- Private labelers with no validated in-house methods
- Brands preparing for regulatory audits or FDA submission
Supplement companies using novel botanicals
Standard ID or potency assays may not apply to your extract, blend, or delivery format. We build methods to match your product and claims.
Skincare and personal care brands with unique actives
New ingredients and natural preservatives often lack validated test methods. We develop assays that support both safety and shelf life claims.
Formulations with complex or interfering matrices
Powders, emulsions, oils, and colored liquids can obscure detection. We refine methods to minimize noise and ensure clarity.
Private labelers with no validated in-house methods
If your manufacturer doesn’t provide documentation or if you’re changing suppliers, you need your own validated procedure.
Brands preparing for regulatory audits or FDA submission
Validated methods help defend your results under scrutiny and are often required for international product registration.
What We Support With Validated Methods
Validated lab methods are essential any time you need precise, repeatable results in support of product quality, compliance, or innovation. At Ayah Labs, we create analytical procedures that meet these goals and go beyond basic testing.
Identity and potency assays for non-standard actives
If your product includes uncommon botanicals, proprietary blends, or rare nutrients, you’ll need validated methods to confirm their presence and quantify their strength.
Impurity and degradation profiling
We develop methods to detect breakdown products, trace contaminants, and unintended ingredients; critical for stability studies, shelf life claims, and compliance documentation.
Assay development for new delivery formats
Gummies, emulsions, tinctures, and powders each require different extraction and analysis protocols. We tailor methods to match the physical and chemical behavior of your product.
Certificate of Analysis preparation
Reliable COAs start with reliable data. We create and validate the methods behind your potency, identity, microbial, or contaminant results so your documentation holds up to scrutiny.
Regulatory submission documentation
For FDA, Health Canada, or international agencies, you need validated methods with method performance data, references, and traceability. We provide what your reviewers will expect to see.
Why Choose Ayah Labs?
We don’t just develop methods; we build confidence. Our process is collaborative, efficient, and aligned with the realities of regulated product development.
Deep expertise in supplements, botanicals, and cosmetics
We understand the unique challenges of plant-based ingredients, emulsions, and complex blends. Our scientists know how to make your formulation testable.
ISO-aligned protocols and traceable documentation
We follow ISO/IEC 17025-aligned principles, ensuring consistency, quality control, and defensible results across every project.
Fast, collaborative R&D turnaround
Method development doesn’t have to drag. We work efficiently and communicate clearly at every step, from concept to validation.
Clear reports suitable for FDA, Health Canada, EU submissions
You’ll receive a complete package including method parameters, raw data summaries, and validation metrics, all designed to withstand regulatory scrutiny.
Support for method transfer to manufacturers or CROs
We don’t just keep the method in-house. We help you transfer it to your manufacturer, third-party lab, or contract research organization with clean documentation and guidance.
Frequently Asked Questions (FAQs)
Build a Method That Works And Proves It.
Don’t leave critical data to chance. Ayah Labs helps you develop and validate the methods your product needs to meet global standards, protect your claims, and scale with confidence.
Start a Custom Method Project