ABOUT CENCORA PHARMALEX
Beginning in January 2024, companies in the PharmaLex family started a journey of rebranding aligned with Cencora, our parent company and 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.
View our content to discover how our expanded capabilities can help you – or contact a Cencora PharmaLex expert today with any questions.
CONTACT INFORMATION
Cencora PharmaLex
1 W 1st Ave.
Conshohocken, PA 19428
UNITED STATES
EXPLORE OUR THOUGHT LEADERSHIP
Explore the latest insights from the Cencora team.
ARTICLES
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This discussion explores critical aspects of maintaining sterility in pharmaceutical manufacturing, from facility design and environmental monitoring to regulatory compliance and common misconceptions.
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The path from groundbreaking therapy to readily available treatment requires a strategic approach. Delve into ten critical questions that can help you chart a successful course for your CGT therapy.
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Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.
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The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.
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Learn how a partnership with a pharmaceutical company to redesign patient support materials resulted in increased patient engagement and copay program utilization.
WHITE PAPERS
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Digital Innovation In Pharmacovigilance
Explore how AI can transform your pharmacovigilance efforts and enhance patient safety by leveraging the insights and decision framework outlined here.
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Mastering The Complexities Of Targeted Medicines
Explore the challenges and strategies involved in developing targeted medicines, with insights into the complexities, collaborations, and considerations necessary for success.
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20 Years Of Biosimilars: Are We On The Right Track?
Explore the transformative journey of biosimilars, 20 years in. Through industry expert insights collected from a recent panel discussion, explore regulatory hurdles, market shifts, and the path ahead.
WEBINARS
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Driving Product Launch Success In Europe
Explore key steps for preparing your medicinal product for the European market, including insights on challenges, timelines, and a success story.
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TMF SUMMER SHORTS: House Of The Inspector
Discover key steps you can take to not just survive an inspection, but take the TMF Throne.
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Unlock The Secrets Of Managing CTR In A Complex Development Landscape
Lost in the CTR maze? Watch this webinar to get your burning questions answered by industry experts. Ask about vendor coordination, CTIS integration, and EU strategies.
PODCASTS
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An Overview Of Contamination Control Strategy (CCS)
Join experts Londa Ritchey and Patrick Nieuwenhuizen as they explore the key role of a contamination control strategy in Annex 1 for ensuring patient safety and continuous manufacturing improvement.
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Early Access Programs: What They Are And How To Plan For Them
Explore how early access programs are tailored to individual sufferers of rare, ultra-rare, or life-threatening conditions, as well as cohort programs, which target groups of patients afflicted with the same disease.
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Assessing Gaps And Achieving Compliance With Annex 1
In this podcast episode on Annex 1 compliance and gap assessment, Patrick Nieuwenhuizen shares his insights and expertise gleaned from extensive experience in pharmaceutical regulation and compliance.
E-BOOKS AND OTHER INSIGHTS
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Navigating The CGT Landscape: Key Takeaways From The FDA's New FAQ
The FDA's new FAQ on cell and gene therapy offers a roadmap for developers. Review key insights from the document, including the importance of early engagement with the FDA, CMC considerations, and more.
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Unraveling The Complexity Of Cell Therapy: Advancements And Challenges
Cell therapy has emerged as a powerful tool for addressing critical medical challenges, but its rapid evolution necessitates a clear regulatory framework and consistent terminology.
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Navigating The Cell And Gene Regulatory Landscape
Navigating the complex regulatory landscape is essential for cell and gene therapy success. Explore key considerations, challenges, and best practices for companies operating in this space.