Method Development & Validation
From feasibility to full validation, we deliver robust methods with traceable data.
Method Development and Validation That Drives Accuracy
When standard analytical methods can’t capture the complexity of your formulation, Aurora creates one that can. We design and validate testing methods that deliver reliable, traceable, and reproducible results, built to meet both scientific and regulatory expectations.
The Challenge: When Standard Methods Fall Short
Products that break new ground often challenge conventional testing approaches. Aurora helps companies overcome analytical limitations by developing and validating custom methods that produce accurate, defensible data.
Unique Formulations Need Tailored Solutions
Innovative formulations, especially those using plant-based, functional, or novel ingredients, can behave unpredictably in standard test procedures. Without a method built for the product, results may vary or fail to reflect real composition.
Regulatory Pressure for Method Validation
Compliance bodies and retailers expect validated analytical methods that demonstrate accuracy, precision, and reproducibility. Reports based on unvalidated methods can delay approvals or raise credibility concerns.
The Cost of Unreliable Data
Unoptimized methods can lead to inconsistent results, incorrect label claims, and inaccurate stability projections. These errors not only impact product quality but also add time and cost to commercialization.
Aurora’s Expertise in Analytical Design
Aurora’s scientists specialize in developing and validating methods that perform reliably across product batches and production environments. Every process we design is built for repeatability, transparency, and regulatory confidence.
Aurora’s Solution: Purpose-Built Methods for Reliable Results
Every product deserves a testing method that fits its composition and purpose. Aurora designs, optimizes, and validates analytical methods that generate consistent, defensible results for research, production, and compliance.
Custom Method Development
Our scientists create new analytical methods tailored to the specific characteristics of your formulation, ingredient, or product category. Each is designed to deliver accurate and reproducible data under real-world conditions.
Method Validation According to Regulatory Standards
Aurora validates analytical methods across key parameters including accuracy, precision, linearity, limit of detection, limit of quantification, and robustness. All validations follow ISO 17025 principles and international guidelines.
Adaptation of Existing Methods
If a published or industry-standard method partially fits your product, Aurora can refine and revalidate it for improved reliability and efficiency.
Application Across Industries
Our method development supports a wide range of products including foods, dietary supplements, natural health items, cosmetics, and pilot-stage pharmaceuticals.
Transparent, Compliance-Ready Documentation
Each validation report includes detailed test data, statistical analyses, and procedural descriptions that meet the expectations of regulatory reviewers and quality auditors.
Why Leading Companies Trust Aurora for Method Development
Successful testing depends on strong scientific foundations. Aurora brings technical depth, regulatory insight, and practical collaboration to every method development project.
- Scientific Rigor at Every Step – Each method is designed and reviewed by specialists who apply internationally recognized analytical standards. Every parameter is documented to ensure traceability and consistency.
- Collaborative Technical Approach – Aurora’s team works directly with R&D, QA, and regulatory professionals to understand the product’s challenges and testing objectives before designing or validating any method.
- Clarity in Reporting – Our reports are structured for usability. They explain the method, outline performance metrics, and summarize key findings in a format suitable for both scientists and non-technical stakeholders.
- Efficiency Without Compromising Accuracy – Aurora maintains a balance between speed and precision. Our timelines are optimized for commercialization without reducing analytical depth or reliability.
- Support That Extends Beyond Validation – We continue to assist clients after validation with method transfer, revalidation, or optimization as products evolve through scale-up and production changes.
Partners Who Rely on Aurora’s Expertise
Aurora collaborates with organizations that need dependable, defensible data for innovative formulations and regulatory submissions. Our method development and validation services support projects across industries that value precision and credibility.
- Food and Beverage Innovators – We help manufacturers introducing new ingredients or functional food products that require analytical methods to verify nutrient content and safety.
- Supplement and Nutraceutical Developers – Aurora designs and validates methods that confirm ingredient potency, purity, and label accuracy for regulatory and retail compliance.
- Cosmetic and Personal Care Brands – Our lab develops analytical methods to measure actives, preservatives, and contaminants in complex formulations such as creams, serums, and natural extracts.
- Pharmaceutical and Life Science Researchers – Aurora supports R&D teams with validated analytical procedures for early-stage or pilot-scale studies that demand high reproducibility.
- Regulatory Consultants and Contract Manufacturers – We partner with consultants and manufacturers who rely on validated third-party data to demonstrate compliance and maintain client confidence.
Each partnership reflects Aurora’s commitment to reliability, precision, and transparent science that drives progress from concept to market.
Common Questions About Method Development and Validation
Why would I need a custom analytical method?
Complex or novel formulations may not respond accurately to existing testing procedures. Custom methods ensure that results are consistent, precise, and relevant to your specific product.
What does method validation include?
Validation confirms that a method performs as intended by assessing parameters such as accuracy, precision, linearity, detection limits, and robustness.
Are Aurora’s validation reports accepted by regulators?
Yes. Our reports are structured according to ISO 17025 principles and align with guidelines recognized by FDA, CFIA, Health Canada, and EU authorities.
Can you modify an existing method instead of creating a new one?
Yes. Aurora can optimize and revalidate existing methods to improve performance, shorten testing time, or enhance detection sensitivity.
How long does method development take?
Timelines depend on complexity, but most development and validation projects are completed within two to four weeks.
Do you provide support after validation?
Yes. Aurora offers ongoing technical support for method transfer, troubleshooting, and revalidation as your product or production process evolves.
Ready to Build the Right Method for Your Product?
Aurora designs and validates analytical methods that meet global quality standards and support confident decision-making. From complex ingredients to novel formulations, our team builds solutions that bring accuracy and assurance to every test.