Approaching Brexit deadline, new licensure will enable continuous global clinical trial operations for sponsors and CROs
HORSHAM, PA. — January 31, 2018. Global Clinical and Ancillary Supply Chain leader Ancillare, LP, the only organization exclusively serving the end-to-end clinical and ancillary supply chain management needs of large- and middle-market pharmaceutical, biotechnology, and medical device companies, as well as contract and medical research organizations, today announced it has been awarded a Wholesale Distribution Authorization (WDA) for Human use by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA).
The award, which comes in response to the United Kingdom’s anticipated departure from the E.U.—commonly called “Brexit”—will allow Ancillare to continue to support study sponsors’ European needs, even while Brexit’s impact on pharmaceutical supply chains remains unclear. The licensure is a critical victory for the dozens of study sponsors, CROs and MROs for whom the U.K. market is a vital link in complex, global clinical trial portfolios and supply chains.
“I think [the license is] a testament to the integrity and dedication of our global team,” said Joanne Santomauro, CEO, Ancillare. “No matter how rapidly or exponentially things have changed on the global stage, we’ll always be ready to respond in service to our sponsors.”
Ancillare received the license following an intensive evaluation, auditing and inspections process. Among the qualifying criteria for the license was that Ancillare was in full compliance with the 2012 Human Medicines Regulations, and with the requirements of Good Distribution Practice (GDP). Ancillare’s WDA will enable ongoing wholesaling and distribution activities—including procurement, holding, supply and export—from its European regional office and master depot in Milton Keynes.
“I’m proud that Ancillare has emerged even better equipped to meet the clinical and ancillary supply chain needs of study sponsors,” Santomauro added.
In response to its confirmed regulatory compliance status, as well as ongoing Brexit requirements, Ancillare anticipates adding staff at its United Kingdom office, in order to drive global expansion efforts throughout Europe, the Middle East, Africa and Asia-Pacific. Ancillare expects to announce the staff changes later in Q1 2018.
About Ancillare, LP
Ancillare is the only organization of its kind with an exclusive focus on the global clinical and ancillary supply chain. Ancillare arms sponsors of global clinical trials with a customized, end-to-end Ancillare Supply Plan, enabling developers of new therapies to optimize their clinical study supply chains using streamlined processes, extensive global buying power, a vast depot network and proven teams of clinical, procurement, operations, logistics and regulatory experts. Ancillare’s Turn-Key Operations (A-TKO™) model embraces the complexities and globalization of the clinical and ancillary supply chain by reducing both the overall cost and cycle time of clinical trials, and greatly improving operational efficiency across all levels of the value chain.
Ancillare has supported more than 1,500 clinical trials across 80,000 clinical sites over 100 countries with master depots in United States, United Kingdom, and Singapore, and strategic depots in Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Israel, Japan, Korea, Mexico, Panama, Peru, Philippines, Russia, South Africa, Taiwan, and Ukraine. To learn more, visit ancillare.com.