ANALYTICAL SERVICES

ANALYTICAL SERVICES

Using our newly built laboratories, we provide a wide range of analytical services to help support your team in compliance with cGMP and ICH guidelines. Our facility is FDA registered and has full European GMP certification.

 

The analytical team supports our customers on a number of different projects including analytical method development and validation. We develop robust and rugged methods through:

  • Developing potency and purity methods;

  • Accuracy and recovery studies;

  • Precision (test/re-test reliability & intermediate precision)

  • Specificity & Selectivity

  • Limit of Detection (LOD)

  • Limit of Quantitation (LOQ)

  • Linearity & Range Samples

  • Stability in Matrix

  • Stock Solutions Stability

  • Specificity

  • Robustness

 

We also provide analytical support services to transfer methods to third-party laboratories or contract manufacturing partners, ensuring a smooth transfer of knowledge.

 

Our analytical chemistry support is available as part of our drug development programs or on a standalone basis to help bolster your existing team.

KEY ANALYTICAL SERVICES

  • Method Development and Validation

  • Stability & Degradation Studies

  • Product Release Studies

  • Physical & Chemical Characterization

  • API Analytical Profiling

  • Technical Consulting

  • Method Transfer