FEI registration will enable release-testing of pharmaceutical raw materials and finished products for the US market
Concept Life Sciences, the integrated drug discovery, development and analytical services company, has achieved FEI (FDA Establishment Identifier) registration and commissioned a 10-fold expansion of its ICH stability storage facilities, to enhance the company’s integrated drug development services offering.
The FEI registration and additional storage capacity allows Concept to release pharmaceutical raw materials and finished products for the US market, as a named test facility, and 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 continuum of analytical support from early method development to commercial launch.
The ability to store bulkier finished products and take on more ICH stability studies allows the company to support customers in assessing physical-chemical stability at all stages of drug development, from lead optimisation to commercial launch and beyond.
Concept has made substantial investment in its stability storage expansion, including qualified storage incubators, supporting infrastructure, and additional analytical laboratory capacity.
Philip Payne, Chief Commercial Officer, said: “To meet the growing market demand for our integrated discovery and development services in the pharmaceutical and healthcare sectors, we continue to invest in physical infrastructure and additions to our quality certifications."
"These new developments provide a continuous analytical service offering from early method development, to release of commercial materials, and also complement our MHRA cGMP certification for the EU.”
Concept Life Sciences has managed full-service storage stability studies for more than 20 years and across all ICH conditions.
This is supported by a comprehensive range of chromatographic, materials characterisation and standard compendial techniques, underpinned by extensive analytical expertise and experience.
The qualified storage incubators are located at Concept’s cGMP-certified pharmaceutical development facilities, which now hold the FEI number and will also release clinical batches of API from its pilot plant facilities.