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news.Pharmaceutical Product Development's (PPD) contract research facility in Athlone, Ireland, has been awarded manufacturer licenses by the Irish Medicines Board (IMB). The licenses support investigational medicinal and marketed products and provide laboratory certifications for quality control of medicinal products.
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PPD said that the new facility will offer product and analytical development services, including method development; validation; stability, release and quality control testing; and global clinical supplies services, including secondary packing, labeling and storage.
PPD has opened its contract research to provide cGMP analytical testing services to its clients. The facility includes an 18,000sqft cGMP analytical testing laboratory and clinical supplies business.
PPD said that the cGMP analytical testing laboratory conducts testing for clinical programs and marketed products spanning all phases of drug development.
The facility is also expected to provide regulatory services, product licensing and marketed product support, including qualified person (QP) services for all drug dosage forms.
Additionally, licensing of the new facility in Ireland is expected to support the growth of PPD’s contract research operations in Ireland, which already operates a medical communications safety call center from Athlone.
Magdalena Mejillano, vice president of laboratory services at PPD, said: “Achieving IMB licensing one month after opening our Athlone facility is a result of our scientific expertise, laboratories and instrumentation and regulatory compliance. From our lab in Athlone, we will provide a full range of small- and large-molecule testing capabilities, including inhaled products, allowing us to meet the changing needs of our clients more efficiently and effectively.”