- PCI Pharma Services successfully completed the ICMRA’s new Collaborative Hybrid Inspection Pilot program, becoming the first CDMO to achieve this milestone.
- The inspection was part of PCI’s $100 million investment in its Bedford, New Hampshire campus, enhancing its sterile fill-finish and lyophilization capabilities.
PCI Pharma Services has become the first contract development and manufacturing organization (CDMO) to successfully navigate the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection process under its new Collaborative Hybrid Inspection Pilot (CHIP) program. The inspection took place at PCI’s Bedford, New Hampshire campus, marking a significant step in global regulatory collaboration.
The CHIP program is designed to expedite the regulatory approval process by allowing multiple countries’ agencies to participate in a single, coordinated inspection. For PCI’s Bedford facility, this meant that two regulatory agencies conducted the inspection—one onsite and one virtually—while an additional five agencies observed virtually. This approach aims to reduce the time required for CDMOs to receive regulatory approvals, streamlining the path from manufacturing to commercialization.
Tom McGrath, VP of Global Quality for Manufacturing & Development at PCI, expressed pride in the company’s pioneering role in this initiative. “We’re honored to have been selected as the first CDMO to participate in the ICMRA’s pilot program, allowing for agencies across the globe to conduct their regulatory approval process simultaneously,” he said.
PCI’s Bedford campus, which specializes in sterile fill-finish and lyophilization for injectable and biologic therapies, was chosen for this pilot program due to its extensive capabilities and recent $100 million investment in infrastructure enhancements. These upgrades have positioned the site as a multi-product, multi-capability campus serving a range of prominent pharmaceutical companies.
Salim Haffar, CEO of PCI Pharma Services, highlighted the benefits of the new inspection process. “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, fast-tracking boost for the pharma industry,” Haffar stated. He added that this process ultimately benefits both pharmaceutical companies and patients by accelerating the production and commercialization of life-changing therapies.
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