PCI Pharma Services

ExpertXchange Webinar Reminder: Navigating Global Trade Complexities in Pharma: Tariffs, VAT, and Free Trade Zones Explained. Book now! Registration Link: https://lnkd.in/exsJhdeM Date: Wednesday 13th August 2025 Time: 8am PT | 11am EDT | 4pm GMT | 5pm CEST  Speakers: Zachary Rupert and Gavin Morgan International expansion brings opportunity but also hidden complexity. For pharmaceutical and biotech companies, seemingly routine cross-border movements can trigger unexpected tariff costs, compliance risks, and supply chain inefficiencies. Join us on Wednesday, 13th August, during our next ExpertXchange webinar ‘Navigating Global Trade Complexities’ as they share insights into tariffs, VAT, and free trade zones (FTZs) and how they impact your clinical and commercial supply chain strategies. Our experts will help you understand:  • Regulatory considerations for importing/exporting APIs, clinical trial materials, and combination products • How leveraging FTZs and custom warehouses can deliver cost efficiencies and supply chain agility • How tariffs and VAT affect pharmaceutical products and biologics across major markets (US, Europe, RoW) • Practical tips for optimizing your global supply chain This webinar will deliver real-world insights to give you the tools to make informed, strategic decisions in a complex trade environment. Whether you’re in supply chain, regulatory, finance, or manufacturing, this webinar will give you the tools to make informed, strategic decisions. #CDMO #SupplyChain #RegulatoryCompliance #LetsTalkFuture

The field of targeted protein degradation (TPD) research is advancing rapidly, driven by ongoing innovations in medicinal chemistry, structural biology, and computational modeling. Over the next five to ten years, we expect a substantial increase in new therapeutic protein drug (TPD) candidates, focusing on enhancing oral bioavailability and expanding druggable proteins. Early engagement with regulatory agencies will be crucial to ensure alignment and avoid delays. Proactive communication can clarify requirements and streamline approvals. Throughout this process, CDMOs will be essential partners, offering regulatory expertise and scalable manufacturing support for stable, high-quality TPD-based therapies. In this expert-led article, Dr. Anshul Gupte Ph.D. RAC Drugs Gupte, VP of Pharmaceutical Development at PCI Pharma Services, dives deep into how a phase-appropriate, science-led development strategy is critical to advancing TPDs from discovery to commercialization and how PCI’s integrated pharmaceutical development model is helping unlock the true potential of TPDs. https://lnkd.in/e9jSM5wK #Biologics #AdvancedTherapies #CDMO #LetsTalkFuture

Integrating formulation science with manufacturing readiness helps de-risk technical challenges, optimize scalability, and accelerate clinical trial supply timelines, ensuring a smooth transition from development through commercialization. In an interview published in International Pharmaceutical Industry, John Ross, SVP of Drug Development & Manufacturing at PCI Pharma Services, shares how PCI is strategically expanding its sterile fill-finish and drug-device combination product capabilities to meet the evolving needs of today’s most complex therapies. From the integration of Ajinomoto Althea’s San Diego site to significant investments in PFS and cartridge technology in the U.S. and Europe, PCI is building an end-to-end network to support scalable, high-quality delivery of sterile injectables. Read the interview to learn more about PCIs: • Expansion of PFS filling capabilities and capacities in North America and Europe • Investment in new sterile drug product, pharmaceutical development laboratories • New annex 1-compliant, isolator based large-scale vial filling and lyophilization line • Clinical to commercial scale injectable filling and drug-device combination product final assembly, testing & packaging Full interview: https://lnkd.in/e2Gxs6xf #CDMO #SterileFillFinish #BioPharma #LetsTalkFuture

Join us in Tokyo for an exclusive evening focused on the latest clinical regulatory developments across the EU and UK — and what they mean for you. Hear from Shawn Murtough, Director of Quality & Regulatory Services, as he shares expert insight on: -QP certification & oversight -Clinical trial regulation updates -Annex 1 changes for sterile products -Supply chain strategies for compliance Event Details: Date: Wednesday, 30 July 2025 Time: 4 - 8PM Venue: Four Seasons Hotel Tokyo at Marunouchi, Japan Following the presentation, there will be a networking reception featuring panoramic city views, drinks, and light bites. Secure Your Spot Today! https://lnkd.in/gMh-nssy #ClinicalTrials #CDMO #SupplyChain #LetsTalkFuture

PCI Pharma Services has received official validation from the Science Based Targets initiative (SBTi) for its near-term and net-zero greenhouse gas (GHG) emissions reduction targets. The SBTi is a global climate action organization that supports companies and financial institutions in taking meaningful action to address the climate crisis. Our targets are validated as science-based and in alignment to limit global warming to 1.5°C, the most ambitious target of the Paris Agreement. This important approval reinforces our commitment to bold climate action and aligns our environmental strategy with the latest climate science. As a global leader in pharmaceutical supply chain solutions, we understand the responsibility we carry. Meeting the urgent challenges of climate change isn’t just about compliance, it’s about doing what’s right for our people, our partners, and our planet. From reducing our carbon footprint to accelerating innovation in sustainable operations, this approval from SBTi marks another step forward in building a healthier, more sustainable future. We are committed. Our ESG Targets: https://lnkd.in/e-f3pe_d   #ESG #SBTi #ScienceBasedTargetsInitiative #LetsTalkFuture

ExpertXchange Webinar: Navigating Global Trade Complexities in Pharma: Tariffs, VAT, and Free Trade Zones Explained. Book now! Registration Link: https://lnkd.in/eTcgvrKv Date: Wednesday 13th August 2025 Time: 8am PT | 11am EDT | 4pm GMT | 5pm CEST  Speakers: Zach Rupert and Gavin Morgan As life science companies expand across borders, the complexity of managing international trade compliance grows with real implications for cost, agility, and regulatory risk. Join us for an ExpertXchange webinar designed to demystify global trade in the pharmaceutical and biotech sectors. This session will provide a clear, practical overview of tariffs, VAT, and free trade zones (FTZs) and how they impact your supply chain strategy. Key takeaways include: • How tariffs and VAT affect pharma and biologics across major markets (US, EU, RoW) • How leveraging FTZs and custom warehouses can deliver cost efficiencies • Regulatory must-knows for importing/exporting APIs, clinical trial materials, and combination products • Practical tips for optimizing your global supply chain Whether you’re in supply chain, regulatory, finance, or manufacturing, this webinar will give you the tools to make informed, strategic decisions. #CDMO #SupplyChain #RegulatoryCompliance #LetsTalkFuture

Press Release: PCI Pharma Services announces strategic investment to support next phase of growth.   We are pleased to share that PCI Pharma Services has entered into a definitive agreement for a strategic investment co-led by Bain Capital and existing lead investor Kohlberg, with significant reinvestment from Mubadala Investment Company and continued support by Partners Group.   This new chapter reinforces PCI’s leading position as a CDMO with ongoing expansion in sterile fill-finish for injectables, high-potent, and specialized capabilities, while further enhancing our pharmaceutical manufacturing and supply chain infrastructure.   Salim Haffar, Chief Executive Officer of PCI Pharma Services, stated: “PCI has embarked on a purposeful journey to transform itself into a global CDMO by executing its successful growth strategy, providing industry-leading customer experience, and offering innovative and integrated supply chain solutions. I am grateful for the ongoing support of our existing investors and enthusiastically welcome Bain Capital and their deep, global healthcare and life science capabilities and expertise.” Full press release and details available here: https://lnkd.in/eMKQDHbR #CDMO #BioPharma #PharmaDevelopment #LetsTalkFuture

For over 25 years, PCI Pharma Services has been a trusted partner in delivering life-changing therapies, providing comprehensive end-to-end solutions for sterile drug development, manufacturing, and lyophilization, from early-phase clinical trials through to commercialization. As demand for high-value biologics, complex formulations, and lyophilized drug products continues to rise, PCI is investing in the future of sterile manufacturing with cutting-edge technology, expanded capacity, and innovative solutions to meet the evolving needs of our clients. Join Jeff Clement at the Outsourced Pharma Fill-Finish Capacity event on Friday, July 18th, to learn about recent developments at PCI Pharma Services, including: • Our expanding clinical-to-commercial scale capabilities and capacities for filling syringes and cartridges in North America and Europe • Our investment in expanding our pharmaceutical development capabilities to de-risk technical challenges, optimize scalability, and accelerate timelines • An update on our Annex 1 compliant late phase clinical and large scale commercial isolator based aseptic vial fill-finish line with twin 430ft2 lyophilizers Register now to discover how we can support your sterile drug product needs: https://lnkd.in/ew7-EyTY... #CDMO #SterileFillFinish #Lyophilization #LetsTalkFuture

As scientific and technological advancements continue to accelerate, the future of Targeted Protein Degraders (TPD) looks exceptionally promising; they’re paving the way for groundbreaking treatments that could redefine the landscape of modern medicine. As scientific and technological advancements continue to accelerate, the future of Targeted Protein Degraders (TPD) looks exceptionally promising; they’re paving the way for groundbreaking treatments that could redefine the landscape of modern medicine. Offering a highly selective and irreversible approach to protein elimination, targeted protein degraders represent a paradigm shift in drug development. Although their optimization presents unique challenges, the expertise of Contract Development and Manufacturing Organizations (CDMOs) is helping to overcome these barriers and enable the successful transition from research to clinical application. In this article, Rebecca Coutts, Senior Director of Pharmaceutical Development, discusses the potential and challenges of Target Product Profiles (TPPs). She addresses issues such as bioavailability, manufacturing hurdles, and the critical role that CDMOs play in enhancing clinical outcomes, as well as how PCI Pharma Services is influencing the future of TPDs through advanced formulation development, high-containment manufacturing, and strategic innovation. https://lnkd.in/eJUttvdj #TargetedProteinDegraders #DrugDevelopment #CDMO #LetsTalkFuture

Join us for an Exclusive Evening of Clinical & Regulatory Insights in Tokyo! Event Details: Date: Wednesday, 30 July 2025 Time: 4 – 8pm Venue: Four Seasons Hotel Tokyo at Marunouchi, Japan Program Highlights: We are excited to welcome Shawn Murtough, Director of Quality & Regulatory Services at PCI Pharma Services, who will present valuable insights on: - Navigating the EU/UK Qualified Person (QP) Process, covering: - Supply chain audits - QP declarations and certification requirements - Product Specification Files (PSFs) - Shelf-life extension and managing regulatory changes - Annex 1 updates for sterile products and compliance strategies Following the presentation, there will be a networking reception featuring panoramic city views, drinks, and light bites. Why Attend? This event offers a unique opportunity to explore the evolving clinical and regulatory landscapes while building valuable connections with peers in pharma, biotech, clinical research, and regulatory affairs. Secure Your Spot Today! https://lnkd.in/gMh-nssy #ClinicalTrials #CDMO #SupplyChain #LetsTalkFuture