Celerion receives license enabling Investigational Medicinal Products (IMPs) to be imported directly to their GMP-licensed facility
The addition of the Import license saves time, costs and initiates direct communication earlier with clients to expedite early stage clinical studies.
(Lincoln, NE; Sep 07, 2011) – Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that its clinical research operations in Belfast, Northern Ireland UK, have received authorization from their competent authority, the Medicines and Healthcare product Regulatory Agency (MHRA) to have importation of IMPs added to their manufacturing (MIA(IMP)) license. The addition to the license enables the elimination of a third party vendor to import IMPs on behalf of Celerion thereby saving time, cost and initiating direct communication with clients to expedite early stage clinical studies.
The import license gives Celerion’s facility in Belfast the ability to import investigational products from outside the European Economic Area when manufacturing standards from the exporting country have been confirmed as equivalent to the standards required by European legislation.
“The addition of the import license was based on client demand and continues to demonstrate the high quality work and experience at Celerion,” said Phil Bach, Vice President of Global Clinical Research at Celerion. “This import license underpins Celerion’s commitment to a global clinical strategy and reduces the lead time from study concept to first dosing. Clients also benefit from reduced costs by eliminating third party storage and transport prior to certification of the product.”
This latest announcement continues to demonstrate Celerion’s commitment to delivering upon the evolving needs of our clients and exemplifies the Belfast team’s commitment to meeting and exceeding our clients’ expectations.
Celerion is the premier provider of innovative early stage clinical research solutions. From facilities strategically located around the world, advanced scientific and technological expertise is applied to clinical research (over 730 beds in Phases 0, I and IIa, NDA – enabling clinical pharmacology, ADME), clinical pharmacology sciences, bioanalytical services (discovery through late stage), and drug development services. Celerion has a full spectrum of resources to meet the needs of the pharmaceutical, biotechnology and generic industries for Phase 0 through IIa proof-of-concept studies. For more information, visit www.celerion.com.