Ingersoll Rand Expands Life Science Capabilities in Lillington, NC

🚀 Join this insightful webinar on “How to Increase the Odds for Success of Your 505(b)(2) Product” and learn practical approaches to navigating the FDA approval process with confidence. Speaker: Dr. Mukesh Kumar PhD, RAC, CEO, Brij Strategic Consultations FDAMap Mukesh Kumar, PhD, MBA, RAC 🔗 Register here: https://lnkd.in/gqrkKZhq 📅 June 4, 2026 Key discussion points include: ✔️ Strategic planning for 505(b)(2) submissions ✔️ Common pitfalls and how to avoid them ✔️ CMC and regulatory considerations ✔️ Leveraging existing FDA data effectively ✔️ Case studies and practical insights for accelerated success For companies transitioning from generics to innovative products, the 505(b)(2) pathway offers a unique opportunity to reduce risk while maximizing market potential. Studies and industry experience show that early FDA engagement and strong regulatory planning can dramatically improve first-cycle approval success. #FDA #RegulatoryAffairs #505b2 #DrugDevelopment #Pharma #ClinicalResearch #CMC #FDAApproval #PharmaceuticalIndustry

🚀 Join this insightful webinar on “How to Increase the Odds for Success of Your 505(b)(2) Product” and learn practical approaches to navigating the FDA approval process with confidence. Speaker: Dr. Mukesh Kumar PhD, RAC, CEO, Brij Strategic Consultations FDAMap Mukesh Kumar, PhD, MBA, RAC 🔗 Register here: https://lnkd.in/gqrkKZhq 📅 June 4, 2026 Key discussion points include: ✔️ Strategic planning for 505(b)(2) submissions ✔️ Common pitfalls and how to avoid them ✔️ CMC and regulatory considerations ✔️ Leveraging existing FDA data effectively ✔️ Case studies and practical insights for accelerated success For companies transitioning from generics to innovative products, the 505(b)(2) pathway offers a unique opportunity to reduce risk while maximizing market potential. Studies and industry experience show that early FDA engagement and strong regulatory planning can dramatically improve first-cycle approval success. #FDA #RegulatoryAffairs #505b2 #DrugDevelopment #Pharma #ClinicalResearch #CMC #FDAApproval #PharmaceuticalIndustry

The final implementation phase of the Drug Supply Chain Security Act (DSCSA) is rapidly approaching. For small dispensers, the Nov. 27, 2026, deadline marks a critical shift in regulatory expectations. The law requires a fully electronic, interoperable system for tracing pharmaceutical products at the package level to ensure patient safety and supply chain integrity. As the window for proactive preparation narrows, understanding how these changes affect your daily operations and wholesaler interactions is more important than ever. Read more: https://lnkd.in/gBW5yT9u

💊 Hawk C-060 Checkweigher — Precision Made Smart Built for pharmaceutical production, the Hawk C-060 delivers ±0.1g accuracy at speeds up to 400 pcs/min, ensuring every product meets strict quality standards. 📋 Designed to support FDA 21 CFR Part 11 compliance, helping ensure secure data handling, traceability, and audit-ready records. 🌐 With Weasy-Link, you can remotely monitor data, debug issues, and analyze performance—anytime, anywhere. Accurate. Intelligent. Reliable. #Pharma #Checkweigher #Automation #GMP #21CFRPart11 #QualityControl

Fewer recalls. Bigger impact. According to Sedgwick’s latest U.S. Product Safety and Recall Index, the volume of recalled products surged 27% in Q1 2026, even as the number of recall events declined. This signals a clear shift: fewer events, but larger-scale disruptions — driven by ongoing supply chain challenges and increasing regulatory scrutiny. From a 12-year high in pharmaceutical recalls to significant growth in consumer product units, the data highlights how complexity is intensifying across industries. At the same time, evolving oversight from agencies like the FDA, FTC, and USDA is raising the bar for compliance, transparency, and communication. For organizations, the focus is clear: Be prepared, stay proactive, and ensure your recall and response strategies can scale when it matters most. Read the full press release: https://bit.ly/3RA7rkQ #ProductSafety #RecallManagement #SupplyChain #RiskManagement #Compliance #InsuranceIndustry

What's causing recalls in your industry? Check out our latest trends in our most recent edition of the Recall Index.

Real-time, continuous clinical trials have been getting the spotlight, but real-time, continuous FDA surveillance and enforcement is quietly gaining momentum. Sedgwick asked for my take on forecasted risk for the pharma industry, and the resulting article (as part of their latest Product Safety and Recall Index report) draws on recent FDA activity to articulate a unified theory of that trajectory. Linking the report here if you'd like to read. #ProductSafety #RecallManagement #SupplyChain #RiskManagement #Compliance #FDA

Annex 1 compliance is not a fixed target. As the pharma industry evolves, so does the lens through which regulators interpret and assess Annex 1 requirements. Christian Dunne Director of Global Corporate Business Development at ChargePoint Technology, provides the solutions to five key questions to pressure-test your aseptic transfer processes against Annex 1 requirements. Read more: https://lnkd.in/ecjTqVha #Annex1 #pharmaindustry #pharmamanufacturing #pharmatech

Thanks Christian Dunne for a great article. Please don't hesitate to get in touch with us if you want to know more about how we can help you achieve Annex 1 compliance.

These questions are key when re‑assessing processes as markets, industry dynamics, and product portfolios evolve. Within the sterile market in particular, periodic evaluation is essential to ensure processes remain fit for purpose as risks, technologies, and standards continue to change.