PharmaLex

Quality management and compliance considerations are essential for a successful commercialization. This is especially true when planning a launch of a medicinal product in Europe (including the UK and Switzerland) given the number of countries to consider! Feel free to reach out for an initial conversation about your commercialization readiness!

Discover how PharmaLex’s QMC division ensures compliance and quality in pharmaceutical manufacturing! Our experts validate equipment and processes, create lean quality systems, and provide experienced auditors to support your journey from clinical trials to commercialization. Learn more about our QMC services here: https://lnkd.in/e_2XZwqt #PharmaLex #QMC #Pharmaceuticals #QualityManagement #Compliance

Explore the latest insights from PharmaLex on the importance of preparing for the Product Management Service (PMS) in the EU! 🏥🌍 Associate Director Hanna Saari outlines the PMS's critical role in ensuring reliable medicinal product data for both regulatory and commercial uses. Key takeaways include: * PMS as a central part of EMA's SPOR program. * Benefits for AI and digital projects through high-quality data. * Support for regulatory and non-regulatory procedures. * Enhanced decision-making and operational efficiencies. * Discover how PMS will shape the future of pharmaceutical data management. Read the full article: https://lnkd.in/dkFPXc6F #PharmaLex #PharmaRegulations #PMS #SPOR #RegulatoryAffairs

Discover how PharmaLex’s QMC division ensures compliance and quality in pharmaceutical manufacturing! Our experts validate equipment and processes, create lean quality systems, and provide experienced auditors to support your journey from clinical trials to commercialization. Learn more about our QMC services here: https://lnkd.in/e_2XZwqt #PharmaLex #QMC #Pharmaceuticals #QualityManagement #Compliance

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Announcing Season 2 of our Summer Shorts: TMF Excellence Edition! Why settle for boring summer reruns when you can join our fresh, informative webinars? Get the latest TMF best practices and guidelines from industry experts to ensure your TMF health with less time and effort. Upcoming Must-Watch Topics: 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗣𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴: 𝗔 𝗡𝗲𝘄 𝗛𝗼𝗽𝗲 | 𝗝𝘂𝗹𝘆 𝟯𝟬𝘁𝗵, 𝟮𝟬𝟮𝟰 Speed up document processing while improving quality. Learn from top-performing companies. 🔗 https://lnkd.in/dqTHKRmN 𝗥𝗶𝘀𝗸-𝗕𝗮𝘀𝗲𝗱 𝗤𝘂𝗮𝗹𝗶𝘁𝘆 𝗥𝗲𝘃𝗶𝗲𝘄: 𝗜𝗻𝘀𝗶𝗱𝗲 𝗢𝘂𝘁 | 𝗔𝘂𝗴𝘂𝘀𝘁 𝟲𝘁𝗵, 𝟮𝟬𝟮𝟰 Master the balance of risk vs. return in your TMF with expert guidance. 🔗 https://lnkd.in/dqTHKRmN 𝗛𝗼𝘂𝘀𝗲 𝗼𝗳 𝘁𝗵𝗲 𝗜𝗻𝘀𝗽𝗲𝗰𝘁𝗼𝗿 | 𝗔𝘂𝗴𝘂𝘀𝘁 𝟭𝟯𝘁𝗵, 𝟮𝟬𝟮𝟰 Prepare for TMF inspections to avoid delays and additional costs. Take the TMF Throne! 🔗 https://lnkd.in/dHmEwnXc Don't miss out on these invaluable sessions! #PharmaLex #TMFExcellence #Webinar #SummerShorts

Unlock the secrets to flawless site inspection readiness with Louise Uí Fhatharta! In this episode of PharmaLex Talks, we dive deep into the essential steps for ensuring your site is inspection-ready. With over 20 years of experience in Microbiology, Quality Control, and Quality Assurance, Louise shares her invaluable insights from leading FDA, HPRA, and DEKRA Health Authority inspections. Don't miss out on this expert guide to operational readiness and compliance. Tune in now to gain the knowledge you need to excel in your industry! 🎧 Listen here: https://lnkd.in/df5Q47hp ⏱️ Duration: 18 minutes #PharmaLex #PharmaLexTalks #Podcast #PharmaceuticalIndustry #QualityAssurance #InspectionReadiness

Unlock the secrets to successful technology transfer in our latest article, published in BioProcess International! Dive into "Keys to Successful Technology Transfer" by PharmaLex QMC experts Olena Chervonenko and Gerardo Gomez, Ph.D. Discover the full article here: https://lnkd.in/dEGNf8-y #PharmaLex #TechnologyTransfer #BioProcessInternational #PharmaIndustry #QMCExperts #Biotech #Pharmaceuticals

🔔 Don't miss out on valuable insights! Watch our on-demand webinar with Louise Uí Fhatharta on "Preparing for Success: How to Ensure a Successful Health Authority Inspection." Learn how to take a proactive approach to inspections and identify key elements of regulatory noncompliance. Watch now: https://lnkd.in/dJyWTNkt #PharmaLex #OnDemandWebinar #HealthAuthorityInspection #RegulatoryCompliance

🌞🎧 Summer Listening Alert! Tune in to our engaging #podcast featuring Quality Director Londa R. as she delves into how a robust quality culture shapes GMP activities. Discover the importance of prioritizing patient safety and implementing best practices in the biopharmaceutical industry. Listen now: https://lnkd.in/d9j4edN9 #PharmaLex #QMC #QualityCulture #PatientSafety #GMP