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Regulatory Compliance Support Services:
Our extensive experience in regulatory affairs is reflected in our inspection history. We provide CMC documentation for your API and provide support for your Investigational New Drug Applications (INDs) and New Drug Applications (NDAs) with documentation to meet regulatory requirements. Our complete API development process is supported by all required analytical services and full GLP/GMP document support, including:
* Development documentation
* Impurity profiles
* Master production records
* Specification development for all materials, intermediates and the API
* Cleaning documentation
* Reserve/retain sample program
* CMC/DMF support
* API stability support
* SOP documentation
* Facility/equipment validation
For more information on our Active Pharmaceutical Ingredients for approved drug products, please see our FDA Approvals.
For details on our regulatory compliance record, please see our Inspection History.