PM Group’s Post

💥 Annex 1 is changing everything in sterile manufacturing. Are you ready for what comes next? The new #Annex1 of the EU #GMP Guidelines is reshaping how we think about aseptic processing – from Quality Risk Management to automation and First Air protection. It’s not just a regulation – it’s a mindset shift toward smarter, safer, cleaner production.   🌟 Meet #GENEX – our answer to Annex 1. At CPHI Frankfurt (October 28–30, 2025), you’ll see how GENEX takes aseptic processing to the next level: 🔹 100% Annex 1 compliant 🔹 Fully automated workflows minimizing contamination risks 🔹 Maximum process safety, efficiency and reliability 🔹 Unmatched flexibility for small-batch applications   #GENEX sets a new benchmark in aseptic processing.   Let’s talk about your challenges, your processes – and how GENEX can make them simpler, smarter, and fully compliant. 📍 Find us at CPHI Frankfurt, Booth 9.0C7 📅 October 28–30, 2025 | Messe Frankfurt We look forward to meeting you in Frankfurt!

“𝙏𝙝𝙚 𝙩𝙧𝙪𝙚 𝙧𝙞𝙨𝙠 𝙞𝙨𝙣’𝙩 𝘼𝙄 — 𝙞𝙩’𝙨 𝙨𝙩𝙖𝙜𝙣𝙖𝙩𝙞𝙤𝙣.” That paraphrased line from Dori Gonzalez-Acevedo article captures perfectly what we aim to tackle with 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝟰.𝟬 — freeing people from paper, empowering better decisions, and rethinking what quality really means. On 𝗧𝗵𝘂𝗿𝘀𝗱𝗮𝘆 𝟲 𝗡𝗼𝘃𝗲𝗺𝗯𝗲𝗿 in 𝗟𝗲𝗶𝗱𝗲𝗻 in the Leiden Bio Science Park, we’ll explore how 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻 𝟰.𝟬 is reshaping pharma — moving from one-time validation to 𝗰𝗼𝗻𝘁𝗶𝗻𝘂𝗼𝘂𝘀 𝗮𝘀𝘀𝘂𝗿𝗮𝗻𝗰𝗲, powered by data and digital systems. We’re joined by three incredible ISPE Pharma 4.0 experts from Germany, Austria and Ireland! • Sana A. (QbDVision) – introducing the new ISPE Validation 4.0 Good Practice Guide • Prof. Christoph Herwig (Körber Pharma) – on Digital Twins in Validation 4.0 • Jörn Volckmann (FrontWell Solutions) – with a forward-looking talk on Validation 4.0 in practice I’m also really proud that my colleague ARUNAVA GHOSH and René Huijnen from Progress - Experts in Life Sciences will present a poster on how recent updates in Guidelines are reshaping expectations for digitalization — and how companies can adapt successfully. 🔗 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗵𝗲𝗿𝗲: https://lnkd.in/ekNKcxZt Let’s move pharma validation forward — one conversation (and one gezellige dinner) at a time. If you are interested in this topic don't hesitate to reach out to us or join your local ISPE group on Pharma 4.0 (e.g. ISPE D/A/CH - Germany, Austria, Switzerland; ISPE United Kingdom Pharma 4.0 COP...). #ISPE #Pharma40 #Validation40 #DigitalTransformation #ContinuousValidation #QualityByDesign #GMP #LeidenBiosciencePark

Clinical Laboratory Services Market to Reach USD 343.58 Billion by 2032 | Rising Diagnostics Demand and Automation Advances Fuels Growth https://lnkd.in/eXTFanix #marketanalysis #marketresearch #marketresearchreports #syndicationservice #pressrelease

The 2025 ISPE Annual Meeting & Expo has been a powerful reminder of how quickly our industry is evolving. Across four days, discussions spanned Pharma 4.0™, regulatory expectations, sustainability, and accelerating speed to market. Through it all, one message stood out: science moves fastest when facilities are designed to keep pace. For AES, these conversations reinforce why cleanroom strategy matters. The environments where therapies are developed and manufactured need to keep pace with innovation, embedding compliance, efficiency, and flexibility from day one. Thank you to everyone who connected with Paul Effler, Jessica Frantz, and Trista Hager. The dialogue doesn’t end here, we look forward to continuing the conversation on how smarter facility design accelerates science safely. #ISPEAM25 #CleanroomDesign #FutureofPharma

Validation is broken and everyone knows it. We spend millions proving systems “work as intended,” yet we can’t even agree on what intended means. We generate mountains of documents, sign them in triplicate, and call it progress, but often, it’s just paper compliance. Validation was never supposed to be a paper pushing exercise. It was meant to prove trust, consistency, and patient safety. Maybe it’s time we stop validating for checking boxes and start validating for patient safety. Read the full article on the f2i partners website under industry insights. #Validation #GMP #Quality #Pharma #Innovation #F2iPartners

CRB‑A3 An update from Crucible ViroGenics We’re announcing CRB‑A3 as a governance‑first therapeutic chassis designed to align innovation with auditable safety and regulatory readiness. CRB‑A3 reframes delivery platforms as governed infrastructure: modular, traceable, and built so containment and clinical performance advance together. What we’re sharing A high‑level overview of CRB‑A3’s modular approach and safety‑by‑design ethos. Summary performance context from our preclinical program and the validation work we are prioritizing. Our commitment to transparent gates and published failure criteria so partners and regulators can assess risk concretely. Why this matters Modularity enables targeted, phase‑sequenced approaches while reducing downstream revalidation burden for iterative payloads. Embedded governance (telemetry, auditability, layered shutdowns) is central — not optional — to accelerate responsible collaboration. We are focused on making acceptance criteria and review artifacts procurement‑ready to shorten decision cycles for clinical and institutional partners. What’s next Complete GLP validations, independent red‑team audits, and pilot GMP runs to support Pre‑IND engagement. Publish redacted, non‑operational summaries for public review and offer confidential technical appendices under NDA for qualified partners and regulators. Host targeted briefings for clinical, regulatory, and procurement leaders to align acceptance metrics and priorities. Call to peers. We welcome technical peer review and partner discussions under appropriate confidentiality. For protocol excerpts, partner briefings, or to schedule a technical review, contact: DavidBirchard@yahoo.com or DM to request a briefing. #GovernanceNative #SafetyByDesign #CRB-A3 #BiotechInnovation #RegulatoryReadiness #ResilienceEngineering

Too many #drugdevelopment programs are hindered by fragmented, multi-vendor outsourcing models—resulting in process inefficiencies, communication gaps, and costly handoffs. What if there were a better way? Turns out, there is. New research from the Tufts Center for the Study of Drug Development shows that integrating #CDMO, CRO, and clinical supply capabilities with a single partner can deliver real results: ✅ Shorter timelines ✅ Reduced costs ✅ Better control Join Thermo Fisher Scientific on November 4, 2025, at 11 a.m. ET to explore the study’s findings and see case-driven examples of how sponsors are already applying these strategies. Sign up here: http://spr.ly/6049A0p1Z

Our media highlights this week show how the firm is at the forefront of society's biggest issues, with our experts leading the conversation on consumer protection, pharmaceutical innovation, strategic M&A, and improving healthcare outcomes. •  Navigating consumer protection: Drapers published an opinion article by Emma Roake and Katharine Mason advising how to avoid ‘misleading discount’ fines this Black Friday. Read more: https://lnkd.in/gNAT-BPt •  Advancing pharmaceutical innovation: The Pharma Letter shared Chris Holder's article on how to navigate legal and regulatory challenges around AI adoption in pharmacovigilance to realise its transformative potential. Read more: https://lnkd.in/eHwyYiDY •  Supporting M&A activity: Construction Wave reported on our advisory role for Phenna Group on its acquisition of Testall, a global testing and inspection company. Read more: https://lnkd.in/ev6mhQH9 • Driving strategic growth: Insider Media reported on our advisory role in key strategic deals: - Millient Software on its acquisition of Cubic Interactive Limited, trading as Rapport3. Read more: https://lnkd.in/gQZBBKsG - Rcapital on its sale of Nasmyth Group to strategic trade buyer Sigma Advanced Systems UK, a subsidiary of Megasoft. Read more: https://lnkd.in/gSGUpBjW - Transvac Systems on its acquisition by NYSE-listed Ingersoll Rand Inc. Read more: https://lnkd.in/gYPrYUG6 • Improving women's healthcare: The Law Society Gazette featured Kelly Buckley's insights on clinical negligence in women's healthcare and the importance of learning from past cases to drive improvements. Read more: https://lnkd.in/gCDmE7Zj #Retail #MergersAndAcquisitions #ArtificialIntelligence #Healthcare #ClinicalNegligence

📌 CDP and Policy 0070 | Expanded Scope ↪ Since May 2025, the scope of #CDP has been expanded with the implementation of Step 2 of the Policy 0070 resumption, including: · All new Initial Marketing Authorization Applications · Line extensions & major Type II clinical variations · Negative opinions and withdrawn applications · Excluding biosimilars, hybrids, and generics · Legacy procedures approved during the policy suspension are now handled “upon request”, with clinical data requests triggering CDP procedures. At ASPHALION, we help you navigate this evolving landscape with expertise and tailored solutions: ✅ Liaison with #healthauthorities ✅ Redaction & anonymization strategies ✅ Execution of anonymization/redaction with Quality Check ✅ Preparation of anonymization reports ✅ Justifications for Commercially Confidential Information ✅ Publishing & submission activities 💡 Simplify your CDP process, ensure #compliance, and save time. 📧 Contact us now! info@asphalion.com #RA #RegulatoryAffairs #WeAreAsphalion #WeCare #KnowledgeFromExperience #Asphalion25Years #Asphalion25thAnniversary #AsphalionQuarterCentury #Asphalion25YearsOfKnowledge https://bit.ly/4qq11Se

BioStem Technologies Responds to CMS's 2026 Final Rule on Skin Substitute Reimbursement “CMS’s final rule represents a decisive step toward a more transparent, predictable, and sustainable reimbursement system,” said Jason Matuszewski, Chief Executive Officer. Click to read the full release: https://hubs.ly/Q03RWcYk0 #CMS2026 #BioStem #BSEM #CMS