Drug discovery, development and analytical services firm Concept Life Sciences has announced its US Food and Drug Administration (FDA) Establishment Identifier (FEI) registration.
As a named test facility, Concept – which was acquired by Spectris in January – is able to support investigational new drug (IND) and abbreviated new drug (ANDA) applications for new and generic candidates.
The registration also means Concept have provide analytical support, from early phase development through to commercialisation.
The firm has seen “significant business growth and opportunity” since receiving its FEI listing, said VP of business development, pharmaceutical development and preclinical, Simon Bristow.
“The firm’s ability to support ongoing routine cGMP (current good manufacturing practice) batch releases of active pharmaceutical ingredients, excipients and finished products to the US ability increases its attention to generic- and development-focused firms.
The FEI number – which is a prerequisite for IND and ANDA submission – also enables the firm to support ongoing routine cGMP (current good manufacturing practice) batch release of actives, critical excipients and finished products to the US market, he added: “This significantly increases our attraction to both generic and development pharma companies.
Storage facility expansion
Concept has also announced plans to expand its International Conference on Harmonisation (ICH) stability storage facilities: “The added storage capacity means that we can now store much bulkier finished products. [It] is a natural extension to our well-established ICH stability services supporting API development and product launch,” Bristow told us.
“Having the additional storage capability, across the full ICH range, places Concept in a unique position to serve our blend of human / veterinary pharma, medical device and advanced wound care clients, extending our highly specialised and integrated discovery and development services,” he added.
The announcement is the latest in a list of significant developments for the Concept. In March 2017, the firm signed a strategic alliance with Metrion to offer fully integrated ion channel drug discovery services, and the following month, Concept acquired preclinical contract research organisation (CRO) Aquila BioMedical.
In September 2017, the company added laboratory space at its Alderley Park-based facility in Cheshire, UK, and in December of that same year, announced plans to double capacity at its East Kilbride analytical services site. In January 2018, Concept teamed up with Alderley Analytical to offer customers bioanalytical and DMPK study services.