Drug discovery company Concept Life Sciences has achieved FDA Establishment Identifier (FEI) registration and has commissioned a tenfold expansion of its ICH stability storage facilities, enhancing the company’s integrated drug development services offering. The FEI registration and additional storage capacity allow Concept to release pharmaceutical raw materials and finished products for the US market as a named test facility and also enables the company to support Investigational New Drug (IND) and Abbreviated New Drug (ANDA) applications for new and generic drugs in development. The registration also enables Concept to provide a consistent analytical support from early method development to commercial launch.
The ability to store bulkier finished products and take on more ICH stability studies also allows Concept to support customers in assessing physical-chemical stability at all stages of drug development, from lead optimisation to commercial launch and beyond. The company has made substantial investment in its stability storage expansion, including qualified storage incubators, supporting infrastructure, and additional analytical laboratory capacity.
For further information about Concept Life Sciences visit www.conceptlifesciences.com
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