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:

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• 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.
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Contact us today to see how the J. Molner team can help you solve your analytical chemistry challenges!
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Check out the virtual tour of our GMP laboratory here.