#WhitePaper 📑 // In an increasingly globalized pharmaceutical landscape, maintaining operational agility is paramount to navigating swiftly evolving regulatory frameworks while upholding top-tier quality and compliance standards. Dive into our latest whitepaper, "𝗥𝗲𝘀𝗵𝗮𝗽𝗶𝗻𝗴 𝗔𝗳𝗳𝗶𝗹𝗶𝗮𝘁𝗲 𝗠𝗼𝗱𝗲𝗹𝘀 𝘁𝗼 𝗦𝘁𝗮𝘆 𝗖𝗼𝗺𝗽𝗲𝘁𝗶𝘁𝗶𝘃𝗲 & 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝘁", offering invaluable insights into the evolving regulatory landscape. Discover strategic solutions to effectively leverage your affiliate models, harmonize regional regulatory standards, and maintain uncompromising compliance while thriving in a fiercely competitive global market. Read more here 🔗 https://rebrand.ly/2ojlphr Stay ahead of the curve and position your organization for success in the dynamic world of pharmaceuticals! #CencoraPharmalex #RegulatoryInsights #AffiliateModels #ComplianceExcellence
PharmaLex
Pharmaceutical Manufacturing
Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains
About us
PharmaLex is now part of Cencora, a leading global pharmaceutical solutions organization centered on improving lives around the world PharmaLex adds to Cencora’s expanding suite of pharma solutions and serves the pharma, biotech, and medtech industries. We guide clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology-elevated solutions to support clients through the entire product lifecycle. Learn more at http://www.pharmalex.com
- Website
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http://www.pharmalex.com
External link for PharmaLex
- Industry
- Pharmaceutical Manufacturing
- Company size
- 1,001-5,000 employees
- Headquarters
- Bad Homburg
- Type
- Privately Held
- Founded
- 1994
- Specialties
- Regulatory Affairs, Pharmacovigilance, Regulatory Operations, Pharmaceutical Quality, Audit / Inspection Preparation, Medical Writing, Biostatistics, Medical Devices, Risk Mangement, Development Consulting, GxP services, and Clinical Trial
Locations
Employees at PharmaLex
Updates
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PharmaLex reposted this
Senior Director and Qualified Person at PLX Healthcare Services (Switzerland), a Cencora PharmaLex company
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
PharmaLex: Quality Management & Compliance
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PharmaLex reposted this
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
PharmaLex: Quality Management & Compliance
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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
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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
PharmaLex: Quality Management & Compliance
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PharmaLex reposted this
Stay informed of all the latest news, events, and thought leadership in the pharmaceutical, biotech and medical device industry! Subscribe to our newsletter for exclusive industry insights about the rapidly-evolving #pharmaceutical industry ➡️ https://lnkd.in/ejiXKmbd #Pharmalex #Newsletter
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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
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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
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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
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🔔 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