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PCI Pharma Services’ Bedford, New Hampshire Location Successfully Completes International Coalition of Medicines Regulatory Authorities Inspection

· 등록일 Aug. 22, 2024 14:05

· 업데이트일 2024-08-23 00:00:14

PHILADELPHIA--(Business Wire / Korea Newswire)--PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), has successfully completed the International Coalition of Medicines Regulatory Authorities (ICMRA) inspection of its Bedford, New Hampshire campus. In doing so, PCI becomes the first drug product CDMO to navigate the multi-agency inspection process, a facet of the ICMRA’s new Collaborative Hybrid Inspection Pilot (CHIP) program, which is focused on the mutual assessment of facilities that manufacture therapies under the organization’s purview.

PCI becomes first drug product CDMO to navigate ICMRA multi-agency inspection process. (Photo: Business Wire) The new ICMRA program is designed to abbreviate the time necessary to receive regulatory approvals from multiple countries. Regulatory agencies from several countries can convene for one inspection as a team, allowing CDMOs such as PCI to attain approval from each of the participating ICMRA countries simultaneously rather than undergo separate, phased inspections. For this pilot inspection, two agencies conducted the inspection - one onsite and the other virtually - while an additional five regulatory bodies observed virtually.

“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,” said Tom McGrath, VP, Global Quality for Manufacturing & Development at PCI Pharma Services. “The program’s collaborative, comprehensive process increases the speed at which CDMOs or sponsoring pharma companies can begin manufacturing, packaging and ultimately commercializing life-changing therapies.”

PCI’s Bedford campus specializes in sterile fill-finish and lyophilization, two manufacturing processes commonly used with injectable and biologic therapies. PCI recently invested over $100 million in infrastructure enhancements at the site, building upon legacy disciplines toward its current destination: a multi-product, multi-capabilities campus servicing prominent pharma companies, across the drug product lifecycle from development to commercialization. Since PCI’s Bedford campus manufactures a broad array of drugs for both domestic and international markets, the site was an ideal candidate for the multi-agency inspection pilot program.

“At PCI, we are dedicated to bringing lifechanging therapies to patients as expediently as possible, and this welcome new program will further enhance our ability to do exactly that,” said Salim Haffar, CEO of PCI Pharma Services. “The ability to simultaneously gain approval from multiple, geographically diverse regulatory agencies is a game-changing, fast-tracking boost for the pharma industry, providing shorter paths to full-fledged sterile drug product production and commercialization, to the ultimate benefit of pharma companies and the patients they serve.”

About PCI Pharma Services

PCI is a world leading CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 90 successful product launches each year and over five decades in the healthcare services business. The company currently has 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain), and over 7,000 employees working to bring life-changing therapies to patients.

Leading technology and continued investment enable PCI Pharma Services to address global drug development needs throughout the entire product life cycle - from manufacturing capabilities through the clinical trial supply chain and commercialization. Its clients utilize PCI as an extension of their business, and a collaborative partner with the shared goal of improving patients’ lives. For more information, visit pci.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20240821206732/en/

Website: http://www.pciservices.com Contact PCI Pharma Services
Turchette Agency
Christopher Dale
(973) 227-8080, ext. 116
[email protected]
This news is a press release provided by PCI Pharma Services. Korea Newswire follows these editorial guidelines. PCI Pharma Services News ReleasesSubscribeRSS PCI 파마 서비스, 뉴햄프셔 베드포드 캠퍼스에서 의약품규제기관국제연합 검사 성공적 완료 선도적인 글로벌 의약품 위탁개발생산조직(contract development and manufacturing organization, CDMO)인 PCI 파마 서비스(PCI Pharma Services, PCI)가 뉴햄프셔주 베드포드 캠퍼스에 대한 의약품규제기관국제연합(International Coalition of Medicines Regulatory Authorities, ICMRA) 검사를 성공적으로... 8월 22일 14:05 Leading CDMO PCI Pharma Services Releases Inaugural Comprehensive ESG Report PCI Pharma Services, (“PCI”) a leading global contract development and manufacturing organization (CDMO), has released its first Environmental, Social & Governance (ESG) Report . A detailed overview of PCI’s multifaceted sustainability journey, the report showcases the strides taken fro... 3월 29일 10:55 ... More  More News Health Pharmaceutical Certification Overseas PCI Pharma Services All News Releases 
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