Method development and validation (DS/DP)

Method development

Depending on your needs, our experienced method development team can develop all relevant methods from scratch, including assays, impurity analyses, dissolution tests and more. Our highly knowledgeable team has extensive expertise in method development. We can also optimise existing methods and adapt them to specific requirements.

Method transfer

Nuvisan offers comprehensive method transfer services that help ensure smooth transitions for analytical processes across various stages of pharmaceutical development.  

Analytical method transfer is the formal process for introducing new methods, enabling the receiving laboratory to demonstrate an effective and reproducible performance. Our effective protocols consider all critical quality attributes and method parameters with a view to maintaining the method's validated state and support continued procedure performance verification. 

Our facilities support transfers in several ways, typically by performing comparative testing, compendia verification or re-validation as broadly described within various regulatory guidelines and USP <1224>. Identified validation gaps can be filled as part of transfer activity. Each method of analysis, specification and method transfer protocol undergoes a thorough technical review before the commencement of transfer activity. At the direction of our clients, we can assume varying degrees of responsibility, from protocol writing, material procurement and risk assessments, to final reports and transfer and training into other quality control laboratories. All transfers are conducted in an open and collaborative manner with quality, regulatory requirements and ultimately patients in mind.

Whether it's an internal transfer between departments or an external transfer to different sites or contract manufacturers, Nuvisan facilitates both comparative testing and co-validation strategies. Our team helps ensure method continuity, risk minimisation, and successful implementation across different laboratories and stages of production. 

Verifications of pharmacopoeia tests

We offer thorough verification of pharmacopeia tests to help ensure the highest standards of quality and regulatory compliance. This includes validating test methods that conform to official pharmacopoeia requirements and confirming the accuracy and reliability of these testing processes. 

Method validation

Analytical method validation is a critical service that helps ensure the robustness, precision and accuracy of analytical techniques used throughout the drug development process.

This service is essential for confirming that testing methods consistently produce reliable and reproducible results, which is crucial for the safety and efficacy of pharmaceutical products. 

Nuvisan’s method validation capabilities cover a broad spectrum of techniques. Our approach adheres to regulatory guidelines and ensures compliance with GMP.  

The validation process involves several key elements, including: 

• Specificity: Helping ensure the method accurately measures the compound of interest without interference from other substances.
• Sensitivity: Determining the method's ability to detect small quantities of the target analyte.
• Accuracy and precision: Verifying that the method can consistently produce correct results under a variety of conditions.
• Robustness: Assessing how the method performs under different conditions to confirm its reliability in varying environments.
• Linearity: Helping ensure the method provides a consistent response over a range of concentrations.

This process supports both small and large molecules, enabling clinical trial support and product release with confidence in the quality of the data produced.

Our skilled scientists adhere to the highest standards in validating these methods, facilitating smooth regulatory submissions and helping clients achieve reliable product development outcomes.