At NJ Labs, we understand that not every sample fits into a standard testing mold. That’s why we offer custom method development and validation services tailored to meet your samples’ unique chemistry, formulation, and regulatory requirements. From early-stage R&D to full-scale manufacturing support, plus FDA deficiencies, our team collaborates closely with you to design, execute, and validate testing protocols that are accurate, compliant, and specific to your sample.
We bring decades of FDA, DEA inspected, experience to every project-whether you’re developing a novel formulation, preparing for a regulatory submission, or transferring methods across manufacturing sites.
Our Custom Method Development and Validation Services Include:
Method Development
We design analytical methods from the ground up, ensuring they are scientifically proven, regulatory-compliant, and tailored to your specific matrix and active compounds.
Method Formulation
At NJ Labs, we partner with clients to analyze and optimize their product formulations to ensure compatibility with analytical testing and long-term stability. Our team provides scientific guidance and real-time testing feedback throughout the development process, helping you refine your formulations for quality, consistency, and compliance.
Method Feasibility
Before investing in full development, we evaluate whether a method concept is practical, reliable, and suitable, with our equipment.
Before advancing to full method development, NJ Labs assesses whether your proposed method is practical, reliable, and compatible with our instrumentation. This early evaluation helps identify potential issues and ensures the method can be successfully executed and supported by our lab in the future.
Method Validation
Partial to Full validation in accordance with ICH guidelines and regulatory expectations, including accuracy, precision, specificity, detection limits, quantitation limit, linearity, range and robustness.
Method Suitability (Microbiology)
We assess compendial and / or other regulated methods that are appropriate for your specific sample matrix and analyte concentration—ensuring the method is applicable and effective.
We evaluate compendial and/or other regulated methods to determine the most appropriate approach based on your specific sample matrix and analyte concentration—ensuring the selected method is both applicable and effective.
We evaluate compendial and / or other regulated methods to determine the most appropriate approach based on your specific sample matrix and analyte concentration—ensuring the selected method is both applicable and effective.
Preparatory Testing (Microbiology – Supplement / Nutraceutical products)
Sample preparation, extraction, and clean-up methods tailored to your matrix and analytical needs, ensuring accurate results from the start.
Method Verification
When compendial methods are used, we verify performance parameters to ensure they perform as expected in your specific sample matrix.
Method Transfer
We support seamless transfer of validated methods between labs or manufacturing sites, including analytical comparisons, bridging studies, and documentation.
At NJ Labs, As a boutique lab, we deliver personalized support that large labs can’t match—ensuring every project gets the attention it deserves. What sets us apart is not just our technical expertise, but our commitment to being a true partner throughout your product development journey.
We Offer :
Have a complex product or a unique challenge? Let’s build the testing strategy that’s right for you.
Reach out to NJ Labs to get started on your custom testing project.
