i-Pharm GxP

Efficient computer and control systems are critical to maintaining compliance, data integrity, and operational excellence in biologics, cell and gene therapy.  i-Pharm GxP optimises, harmonises, and implements systems tailored to end-user needs, ensuring seamless integration and regulatory alignment. We provide expertise in: ✅ QMS solutions (TrackWise, eQMS, MasterControl) ✅ LIMS, RIMS & Labware for streamlined data management ✅ MasterData & KNEAT for controlled documentation ✅ ERP solutions (Netsuite, Oracle ERP Cloud) ✅ Process automation with Johnson Controls, GE Digital, Siemens, Honeywell, and Emerson Systems Our specialists train teams, enhance system efficiency, and ensure compliance, allowing organisations to focus on delivering life-saving therapies. 📌 Looking to optimise your systems? Let’s discuss your needs: https://lnkd.in/enau36DV #Biologics #CellAndGeneTherapy #Automation #LifeSciences #iPharmGxP

AstraZeneca’s SERENA-6 trial has delivered positive Phase III results for camizestrant, an oral selective estrogen receptor degrader (SERD), in combination with CDK inhibitors. This marks a potential shift in the treatment landscape for HR-positive, HER2-negative advanced breast cancer with ESR1 mutations. With the success of camizestrant, AstraZeneca continues to strengthen its oncology pipeline, following recent advancements with Truqap and Datroway. ___________ How do you see this development shaping the future of endocrine therapy? Share your thoughts below. ⬇️ #LifeSciences #iPharmGXP #AstraZeneca

🍀 Happy St. Patrick’s Day from i-Pharm GxP! 🍀 Today, we’re celebrating the Irish spirit of resilience, excellence, and community, values that drive us every day in supporting our clients and contractors across the GxP sector. If you're a client looking to ensure compliance and excellence in your projects, our Client Services team is here to help. Phillip Dumont Connor Rankin Fernando Rodriguez If you're a contractor seeking your next opportunity, our consultants are ready to connect you with the right projects. Hamish Corson Harry Reeve Wishing everyone a fantastic St. Patrick’s Day! Sláinte! ☘️ #StPatricksDay #LifeSciences #GxP #QualityExcellence

What’s next for Healthcare Technology in 2025? From AI advancements to personalised medicine, healthcare technology is poised for transformative change this year. Emerging trends like smart devices, predictive analytics, and decentralised clinical trials are reshaping the industry and creating new opportunities. 💡 Swipe through the highlights to see the key trends driving innovation in 2025. _______________ What trends are you most excited about? Share your thoughts below! ⬇️ #HealthcareTechnology #Innovation #LifeSciences #MedTech2025

The Cell and Gene Therapy Catapult has released its January 2025 Regulatory Round-Up, highlighting key updates from MHRA, EMA, FDA, and ICH that could impact the sector. From new medical device regulations to AI’s role in regulatory decision-making, staying informed is essential. Swipe through for a quick summary of the most important announcements. 📌 Read the full regulatory round-up here: https://lnkd.in/ege6F_vS #iPharmGXP #CellandGeneTherapy #Insights

Today, we celebrate the achievements, resilience, and contributions of women around the world. At i-Pharm GxP, we are committed to championing diversity, equity, and inclusion, not just today but every day. From advocating for women in STEM to ensuring equal opportunities in life sciences recruitment, we continue to push for positive change. Who is inspiring you this International Women’s Day? Leave us a comment below. #InternationalWomensDay #IWD2025 #iPharmGxP

Meeting sterile manufacturing regulations demands expertise and a proactive approach. i-Pharm GxP works to comply with regulatory bodies including FDA, MHRA, EMA, COFEPRIS, and PMDA to help clients secure approvals and maintain sterility standards. We manage and deliver regulatory initiatives across: ✅ CMC strategy to ensure product quality and consistency. ✅ Regulatory submissions for NDAs, BLAs, ANDAs, and ODDs. ✅ 510(k) and PMA applications for sterile medical devices. From investigational approvals to full market authorisation, we provide the expertise needed to navigate complex regulatory landscapes. 📌 Planning a project? Let’s discuss how we can help: https://lnkd.in/enau36DV #SterileManufacturing #AsepticProcessing #RegulatoryAffairs #LifeSciences #iPharmGxP

Know someone looking for their next role in Life Sciences? Help someone take the next step in their career—and get rewarded for it! Refer them to i-Pharm GxP and you could earn up to $2,000 in gift cards! 💸 We’re currently hiring for key roles in the industry, and your network could be the perfect fit. 📩 To submit a referral, send the candidate’s resume and full contact details to: Harry Reeve - [email protected] Hamish Corson – [email protected] #Referral #iPharmGxP #LifeSciences #Hiring

Every client, assignment, and location presents a unique challenge. That’s why at i-Pharm GxP, we take the time to truly understand your project from every angle, not just the technical, but also the cultural, logistical, and human aspects that drive success. Every scope is treated with complete confidence, safeguarded by NDAs that allow us to collaborate openly and design the best path forward. If you’re curious about how we can help you achieve your next project milestone, drop us a message or comment below. 💬 #LifeSciences #iPharmGXP

The FDA’s 2024 guidance on aseptic processing is driving the industry toward risk-based contamination control and predictive monitoring. Companies must adopt a more dynamic approach to environmental monitoring, focusing on prevention rather than reactive measures. Key things to know: 🔹 Environmental Monitoring: Continuous, real-time tracking with advanced sensors to detect microbial contamination. 🔹 Contamination Control: Proactive risk management to reduce contamination risks before they occur. 🔹 Personnel Training: Enhanced operator training and stricter protocols. These changes are setting higher standards for sterility and creating new opportunities for innovation in cleanroom management. How is your organisation preparing to meet these new expectations? Let us know in the comments! ⬇️ ______________ Want to read the full FDA guidelines? Have a look here: 🔗 https://lnkd.in/e4f2i89D #AsepticProcessing #RegulatoryCompliance #iPharmGxP