Concept Life Sciences — integrated drug discovery, development and analytical services company — has achieved FDA Establishment Identifier (FEI) registration and commissioned an expansion of its services as a result.
Business growth
Through the FEI registration the company is expanding its ICH stability storage facilities by 10-fold in order to enhance its integrated drug development services offering. This in turn will enable 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 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.
“In order 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,” explained Philip Payne, chief commercial officer. “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.”