Our characterization services for NCEs, generics and first generics help assess the quality characteristics of drug products like physical and chemical properties, which are primary elements to ensure the desired quality, considering the safety and efficacy of the drug product. We help to understand physical, chemical and microbiological properties or characteristics that should be within an appropriate specification to ensure the desired product quality.
Aurigene is equipped with dedicated High potent Analytical Lab for handling of Drug Products containing High Potent / Cytotoxic API’s, with the below set of instruments.
Experience with various characterization techniques
Expertise and multi disciplinary skill set team
USFDA-inspected labs with advanced instrumentation
Understanding of various regulatory and pharmacopeial requirements
Specialized separate expertise team exist for handling advanced instruments
Phase appropriate Analytical methods developed and validated
New generation digitaIized tools exist for the execution of all analytical activities.
Dedicated Project manager exist for driving the project mile stones.
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