Within the context of drug product and substance testing, method development and validation constitute the backbone of the analytical work as well as the legal framework. Chromak Research is a prominent contract testing laboratory. We design and validate analytical methods for ensuring the quality, identity, purity, and stability of products in pharmaceuticals, biotechnology, nutraceuticals, and chemical manufacturing.

Method Development and Validation USA

What is Method Development?

Reliability in any testing process begins with method development. It includes the design of analytical procedures where a sample or product will be assessed both qualitatively and quantitatively in a measurable way. As part of your regulatory obligations, at Chromak Research, we work hand-in-hand with clients through our sophisticated analytical chemistry team to design methods that abide by your boundaries and standards.

Our services for method development entail preparing a detailed plan which includes following steps:

Selecting the most appropriate methods of analysis (HPLC, GC, UV-Vis etc.)

Designing the chromatographic method optimally

Formulating a plan for preparation of the sample

Set up the limits of detection and the response factors

Conducting preliminary trial runs to check for accuracy and precision.

Importance of Method Validation

As with any other method, method validation is the final step after developing an analytical method to check if it fulfills the requirements of dependability, precision, and accuracy of results. It affirms whether the method is appropriate for its intended application for quality control, regulatory submission, or normal product testing.

At Chromak Research, we specialize in method validation after the API testing stage (Q2(R1)). We check the following:

  • Accuracy and precision.

  • Specificity and linearity.

  • Determination of range.

  • LOD – Limit of detection.

  • LOQ – Limit of quantitation.

  • Method robustness

  • System Suitability.

We test further by proving the stability of these methods when applied in other laboratories, by other operators, or through different instruments to check for consistency and repeatability under diverse circumstances. This lessens the amount of variability and increases the certainty of your information for regulatory approval.

Comprehensive Support for All Product Phases

Chromak Research is ready to assist you on any level of the value chain, such as raw materials, active pharmaceutical ingredients (APIs), intermediates, or even finished drug products. It’s our goal at Chromak to facilitate all your method development and validation services to be in sync with your product development cycle, ranging from prototype to commercialization.

Every client has a compliance deadline, and almost all clients have time deadlines as well. With more than three decades of industry experience, we don’t just provide technical services; we also offer strategic consulting that helps you get approved faster and ready for the market sooner.

What makes Chromak Research special?

Achieving Chromak Research goals also requires:

Construction of new and modification of existing analytical methods, their validation, and execution of tests according to developed standard operating procedures.

Auditing of SOPs and testing documents, routine testing documents on compliance with audited documents and approved documents, and identifying procedural gaps.

Known procedures developed and implemented by a laboratory are presented to clients as conflicting with regulatory alignment and resulting in international standard compliance.

We are legally bound to protect your intellectual property and guarantee the confidentiality of information disclosure.

We continuously meet our deadlines—no exceptions.

Work with Us for Trustworthy Method Development & Validation

Chromak Research Laboratory is your go-to contract testing lab if you need assistance with analytical method development and validation during your product development cycle. Allow us to make sure that your determination methods are correct, precise, compliant, and ready for a successful product lifecycle with building block compliance in place.