PA-PCI-PHARMA-SERVICES
21.8.2024 17:01:33 CEST | Business Wire | Press release
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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240821206732/en/
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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240821206732/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 03:45:00 CEST | Press release
EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 01:56:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release
FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release
In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom