PCI Pharma Services achieves milestone with successful ICMRA inspection at Bedford facility

PCI Pharma Services, a leading global contract development and manufacturing organization (CDMO), has reached a significant milestone by successfully completing the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire facility. This accomplishment positions PCI as the first CDMO to navigate the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program. This program is aimed at streamlining the regulatory approval process by allowing multiple agencies to conduct a single, coordinated inspection.

The ICMRA’s CHIP initiative is designed to shorten the time required for regulatory approvals by enabling a unified inspection process. Instead of undergoing separate inspections in different countries, CDMOs can now receive approvals from all participating regulatory agencies in a single, collaborative assessment. For this pilot inspection, two regulatory agencies conducted the review—one on-site and one virtually—while five additional agencies observed the inspection remotely.

PCI’s Bedford facility, known for its specialization in sterile fill-finish and lyophilization processes, was selected for the pilot program due to its extensive capabilities and recent infrastructure investments. The site has undergone over $100 million in upgrades, enhancing its ability to manufacture a wide range of drug products for both domestic and international markets. This facility’s expertise in handling injectable and biologic therapies made it an ideal candidate for the multi-agency inspection pilot.

Tom McGrath, Vice President of Global Quality for Manufacturing & Development at PCI Pharma Services, expressed his appreciation for being chosen for the pilot program. “We’re honored to be the first CDMO selected for the ICMRA’s pilot program,” McGrath said. “This collaborative approach significantly speeds up the regulatory approval process, allowing us to bring life-changing therapies to market more quickly.”

Salim Haffar, CEO of PCI Pharma Services, emphasized the transformative impact of the new inspection program. “The ability to simultaneously gain approval from multiple regulatory agencies is a significant advancement for the pharmaceutical industry,” Haffar noted. “This new program will accelerate the path to full-scale drug production and commercialization, benefiting both pharmaceutical companies and the patients they serve.”

The successful completion of the ICMRA inspection underscores PCI Pharma Services’ commitment to advancing pharmaceutical manufacturing and improving the speed at which new therapies reach patients. The company’s Bedford facility now stands as a testament to the effectiveness of the ICMRA’s innovative approach to global regulatory inspections.