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Method Development & Validation

Eliminate Risk with Proven Methods

When unreliable testing slows progress or risks compliance, trial and error is not an option. At Quantum, we deliver proven method development and validation services that ensure accurate, repeatable results so you can move forward with confidence. With over 30 years of experience, our scientists design fit-for-purpose analytical methods using a wide range of analytical techniques. Whether developing new methods or remediating existing ones, we tailor solutions to your products and challenges. We specialize in developing rugged, stability-indicating methods for APIs, drug formulations, cosmetics, personal care, and raw materials, covering the full lifecycle from development and validation or verification to transfer.

Methods
Developed

Purity

Molecules/Materials with Unique Complexity or Purposes

Stability Indicating Methods

ICH Q11/Q14 Support

Potency

Impurities

Robust Methods for Fast Method Transfer

Attributes
Evaluated

System Suitability

Evaluation of Limit of Detection (LOD) & Limit of Quantitation (LOQ)

Linearity

Evaluation of Range

Accuracy

Precision

Sample Stability

Standard Stability

Where Method Development & Validation Testing
Makes the Difference

Define Your Testing Needs
We collaborate to understand your product, regulatory requirements, and testing goals

Develop the Method
Our experts select the right analytical techniques and refine them for precision, sensitivity, and reproducibility

Validate the Method
We perform rigorous validation to confirm accuracy, precision, linearity, specificity, and robustness

Deliver Compliance
You receive complete, audit-ready reports and documentation for regulatory submissions

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New Product Formulations
Create accurate, reliable testing methods before introducing a new product to market. 

Process Optimization
Improve current analytical testing methods for greater speed, accuracy, and cost efficiency.

Regulatory Compliance
Validate existing methods to meet FDA, USP, ISO, or other strict testing standards. 


 

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We're Not Just a Lab, We're a Testing Partner You Can Rely On

Built for Regulated Industries

30 years of solving complex product and compliance challenges

Real People. Real Answers.

Work directly with scientists who guide you, not just test for you.

Testing That Goes Deeper

We don’t just test — we troubleshoot, explain, and guide.

Ready to Get Results You Can Trust?

Book a consult with our team to discuss your goals, get expert input, and map out your next steps — with no pressure, just clarity.

BOOK A CONSULT