PCI Pharma Services

Be part of a live virtual open house based at PCI Pharma Services in Burlington, Canada! Don't miss this opportunity! No travel. No time away from your desk. Take part from anywhere in the world for an exclusive behind-the-scenes tour of the PCI Burlington facility. Discover how our Canadian hub supports global clinical studies with best-in-class packaging and distribution strategies, controlled substance management, cold chain expertise, and efficient depot solutions. Join us on Nov 6, 2025, at 11AM EST for: - Live Q&A with PCI's technical experts - See our Quality & Packaging operations in action Learn how utilising our Canadian strategy can accelerate your clinical supply chain. Register now: https://lnkd.in/erdJYEEX #CommercialPackaging #ColdChain #CDMO #LetsTalkFuture

The 2023 revision of EU GMP Annex 1 has redefined expectations for sterile pharmaceutical manufacturing, placing greater emphasis on contamination control, risk-based quality management, and aseptic process robustness. Mindy Gagnon, MS, Senior Director of Quality at PCI Pharma Services, shares with PHARMAnetwork magazine insights into the principles of Annex 1 and how manufacturers are adapting to meet these heightened expectations through: • Comprehensive contamination control strategies (CCS) • Adoption of isolator and barrier technologies • Enhanced environmental monitoring and digital integration • Continuous training and qualification of aseptic personnel • Robust media fill programs and process validation At PCI, compliance is more than a regulatory requirement; it’s a cornerstone of our quality-driven culture. Through investment in isolator-based aseptic filling technologies, automated lyophilization, real-time environmental monitoring, and digital quality systems, we ensure our sterile fill-finish operations meet and exceed today’s regulatory standards. Our Quality Assurance teams lead a proactive, lifecycle-driven approach across all sites from new facility builds and equipment qualification to process validation and continuous improvement, while ensuring clients benefit from the highest levels of sterility assurance, regulatory readiness, and patient safety. Read the full article here: https://lnkd.in/e2-8Ec5D #Annex1 #PharmaManufacturing #CDMO #LetsTalkFuture

As global pressures reshape supply chains, agility and long-term planning have never been more critical. Tim Roberts, Chief Commercial Officer at PCI Pharma Services, recently sat down with EPM (European Pharmaceutical Manufacturer) to share his perspective on the current pharmaceutical contract manufacturing landscape, the future of CMOs/CDMOs, and how PCI is helping clients navigate this change. Key Takeaways from the interview: - The rise of complex modalities, including biologics, cell & gene therapies, and targeted therapies like TPDs, demands deeper expertise and advanced capabilities. - Supply chain resilience is more important than ever, with regionalization and strategic sourcing top of mind. - Digital transformation from automation to advanced analytics is now a baseline expectation for reliable, scalable manufacturing. - Clients are seeking true partnerships, built on transparency, agility, and long-term collaboration. - Sustainability and ESG credentials are increasingly influencing partner selection. Read the full interview here: https://lnkd.in/eZ6Yirhn #CDMO #PharmaManufacturing #SupplyChain #LetsTalkFuture

The countdown is on, PCI Pharma Services is heading to CPHI Frankfurt! Next week, we will join the global pharma community to showcase how PCI delivers seamless, end-to-end solutions that accelerate therapies from development to commercial launch. Meet us at CPHI Frankfurt, 28th - 30th October 2025, and visit Stand #5.1C58 to learn how we’re advancing the future of pharmaceutical innovation. #CPHIFrankfurt  #AtTheHeartOfPharma  #CDMO #LetsTalkFuture

Join David O’Connell, Director of Scientific Affairs at PCI Pharma Services, at CPHI as he explores cutting-edge bioavailability enhancement strategies—from hot melt extrusion and nanomilling to spray drying and nanotechnology. Discover how PCI’s strategic partnerships and integrated, end-to-end development solutions are helping bring the next generation of complex molecules to life. 30 October 2025 1:15 PM – 1:40 PM Manufacturing 5.0 – Hall 4.1 Product Innovation session Don’t miss this deep dive into the science driving tomorrow’s targeted oral therapies. #CPHI2025 #TargetedProteinDegraders #CDMO #LetsTalkFuture

Justin Schroeder, Global Vice President of Technical Sales at PCI Pharma Services, will be a speaker on the Combination Devices Panel at PODD 2025. Justin will share his perspective on ensuring sustainability throughout drug and device development. He will bring his expertise to a critical discussion on how the industry can: - Embed sustainability into core development principles - Design combination products with lower carbon footprints - Build circular recycling models that support long-term impact. Don’t miss the opportunity to gain first-hand insights from Justin and other leaders driving sustainable innovation in drug-device development. More event info: https://lnkd.in/ghFUQHfS #PODD2025 #CDMO #Sustainability #LetsTalkFuture

We are pleased to announce that Lori Jackson, Senior Director of Global Digital Quality and Program Management at PCI Pharma Services, will be participating in an executive roundtable at The Industrial Transformation Event, hosted by LNS Research, on October 29, 2025. This interactive session will bring together industry leaders to discuss the strategies and frameworks required to build agile, efficient, and future-focused industrial operations. Key discussion points will include: • Aligning operations with enterprise-wide objectives to achieve measurable impact • Balancing cost, quality, responsiveness, and innovation through resource prioritization • Enhancing resilience and adaptability in the face of ongoing market and supply chain challenges As an organization committed to operational excellence, PCI is proud to contribute to conversations that shape the future of industrial strategy and help ensure the reliable delivery of life changing therapies to patients. Learn more: https://lnkd.in/eU-PHddm #DigitalTransformation #CDMO #PowerOfExperience #LetsTalkFuture

In our latest Expert Insights article, Dawn Manley, Director of Global Technical Sales at PCI Pharma Services, explains why addressing packaging and device needs early in clinical development is critical to managing risk, accelerating timelines, and ensuring regulatory readiness. Dawn shares how collaboration between technical and commercial teams, supported by PCI’s integrated sterile manufacturing and assembly capabilities, helps clients bring complex injectable products to patients with confidence. Read the full article: https://lnkd.in/eYayir-3 #CDMO #ExpertInsights #LetsTalkFuture

PCI Pharma Services is looking forward to joining industry leaders at PODD 2025 in Boston, where our experts will showcase the latest in advanced drug delivery innovation. October 27–28, 2025 Westin Copley Place Booth #210 Our team will highlight PCI’s Advanced Drug Delivery (ADD) capabilities. From sterile fill-finish and lyophilization to the specialist packaging of autoinjectors, prefilled syringes, and drug-device combination products, we deliver end-to-end injectable solutions to support biopharma partners in optimizing dosing and creating convenient, patient-centric therapies. Connect with us at PODD to learn how we deliver solutions that move therapies forward. For more information and to arrange a meeting in advance: https://lnkd.in/eNJCuuCN #PODD2025 #AdvancedDrugDelivery #CDMO #LetsTalkFuture

Autoinjectors are emerging as pivotal technologies in the evolving landscape of injectable therapies. In this issue of International Pharmaceutical Industry Journal, PCI Pharma Services' William Welch explores how autoinjectors are reshaping clinical trials and accelerating the shift to patient-centric drug delivery. As therapies increasingly target chronic and rare diseases, the ability to self-administer at home is no longer optional; it's an expectation. Autoinjectors represent a transformative shift in drug delivery and deliver clear benefits for patients and sponsors alike: • Improved compliance and retention • Standardized, reproducible dosing • Enhanced real-world data to support regulatory submissions and commercialization Bill shares his expert insights, highlighting the importance of early integration of autoinjectors in clinical trials, addressing key considerations such as device–drug compatibility, human factors, regulatory pathways, and global adoption trends. At PCI, we partner with clients worldwide to bring life-changing injectable therapies to patients with agility, precision, and patient-focused innovation. Full Article: https://lnkd.in/eYjGHVqY #AdvancedDrugDelivery  #CDMO #PatientCentricity #LetsTalkFuture