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ANALYTICAL SERVICES

ANALYTICAL SERVICES

KEY ANALYTICAL PROGRAMS

Using our newly built and expanding laboratories, we provide a wide range of analytical services to help support your team in compliance with ICH/FDA/EMA guidelines. Our facility is FDA registered and has full European GMP certification with a MRA between the EMA and FDA (Mutual Recognition Agreement (MRA) | FDA) for site inspections. 

 

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:

  • Validated Method Optimization

  • 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 

  • Stability of Analytical Solutions

  • 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. We combine these services with our regulatory expertise to provide a comprehensive platform and report for rapid product launch and successful review by appropriate regulatory authorities.  
 
Our analytical chemistry support is available as part of our drug development programs or on a stand-alone basis to help bolster your existing team.

Contact us today to see how the J. Molner team can help you solve your analytical chemistry challenges!

Check out the virtual tour of our GMP laboratory
here.

  • Method Development and Validation as per ICH/FDA/EMA guidelines

    • Assay (HPLC/GC)​

    • Impurities (HPLC/GC)

    • Residual Solvents (GC) 

    • Dissolution/Drug Release

    • (UV/HPLC/GC)

    • IVRT/IVPT Studies (SUPAC-SS)

  • Comprehensive Stability Studies

  • Degradation Studies

  • Physical & Chemical

  • Characterization

  • API Analytical Profiling

  • Technical Consulting

BOOK A 30 MIN CONSULTATION

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