CMC analytical support

Leveraging state-of-the-art technology and rigorous scientific methodologies, we provide a full spectrum of CMC analytical support, including:

·         Method Development and Validation  

·         Cleaning Validation

·         Stability Testing

·         Dissolution Studies (including TIM1/TINY TIM gastro-intestinal model)

·         Orthogonal Methods Development 

·         Impurities Identification and Isolation 

·         Elemental Impurities Determination (ICH Q3D)

·         Nitrosamines Determination and Testing

·         Pyrrolizidine Alkaloids (PAs) Determination and Testing

·         Dioxins and Furans Analysis 

·         Glycols Analysis 

·         Extractables & Leachables Services

·         Microbiological Testing

·         Analytical Characterization 

·         Release Testing