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An ISO 13485 certificate doesn’t exempt you from FDA inspection. Since February 2, 2026, the FDA’s QMSR incorporates ISO 13485:2016 by reference. US device inspections now follow the ISO clause structure, and your internal audit, supplier audit, and management review records are open to FDA investigators. Your internal audits matter more than ever. To help you prepare, we created a free, interactive ISO 13485:2016 audit checklist. Here’s what you can do with it: ✅ Review requirements across Clauses 4–8 ✅ Automatically build a list of gaps ✅ Add an optional FDA QMSR section for US manufacturers ✅ Save your work directly in your browser The accompanying article also looks at common audit findings, including CAPAs that stop at “human error” and QMS software that hasn’t been properly validated. Read more: https://lnkd.in/evwNUCcg #ISO13485 #FDAQMSR #MedicalDeviceQuality #QualityManagementSystem #FDACompliance #MedicalDeviceManufacturing #DESPharma #PharmaConsulting

Kisco Pharma Solutions and DES Pharma Consulting Announce Strategic Transatlantic Partnership! We’re pleased to announce a strategic partnership between KISCO Pharma Outsourcing Solutions and DES Pharma Consulting, connecting complementary expertise and industry networks across Europe and the United States. Together, we will provide biotech, medtech, and pharmaceutical companies with flexible, integrated support from early development through commercial launch—combining strategic guidance with hands-on expertise across CMC, technical operations, quality, regulatory affairs, clinical operations, procurement, and supply chain management. By bringing together KISCO’s established European network and flexible resourcing model with DES Pharma Consulting’s US-based expertise, we aim to help clients scale resources, strengthen operations, reduce risk, and reach critical milestones without adding permanent headcount. From lab to launch. One flexible team across Europe and the USA. Read more about the partnership: https://lnkd.in/gCmhmTaM #KISCO #KISCOPharma #DESPharma #LifeSciences #Biotech #Pharma #CMC #StrategicPartnership #PharmaceuticalManufacturing #DrugDevelopment #Biopharmaceuticals #SupplyChainManagement #PharmaConsulting #PharmaConsultants

From conjugation and DAR control to analytical strategy, technology transfer, high-potency containment, and supply-chain resilience, ADC development requires more than great science—it requires the right processes, partners, and CMC strategy working together. If you’re working on an ADC program and facing a development, CMC, analytical, quality, or supply-chain challenge, let’s connect in San Diego. World ADC Event Series October 12–15, 2026 Town and Country Resort | San Diego, CA

Heading to World ADC San Diego 2026? Meet DES Pharma Consulting there. From conjugation and DAR control to analytical strategy, technology transfer, high-potency containment, and supply-chain resilience, ADC development requires more than great science—it requires the right processes, partners, and CMC strategy working together. If you’re working on an ADC program and facing a development, CMC, analytical, quality, or supply-chain challenge, let’s connect in San Diego. 👉 Book a meeting with DES Pharma: https://lnkd.in/gdMUPPw7 World ADC Event Series October 12–15, 2026 Town and Country Resort | San Diego, CA #WorldADC #ADCDevelopment #AntibodyDrugConjugates #PharmaceuticalDevelopment #CMC #Biopharmaceuticals #DESPharma #PharmaConsulting #ADCSanDiego

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Big News! We're excited to announce a strategic alliance between DES Pharma Consulting and Adept Group (Adept Packaging). By combining our expertise, we're helping biotech and pharmaceutical companies move more efficiently from development to commercialization—from CMC and quality to pharmaceutical packaging and product launch. Together, we're providing a more connected approach to bringing therapies to patients. One integrated path. From molecule to market. Here is the press release: https://lnkd.in/gBDs28R8 #Biopharma #Biotech #DrugDevelopment #CMC #PharmaceuticalPackaging #Commercialization #PharmaConsulting #LifeSciences #RegulatoryAffairs #StrategicPartnership #DESPharma #AdeptPackaging #AdeptGroup #DESPharmaConsulting