Cencora OUTPH Insights
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Essential Strategies For Mastering CMC And Avoiding CRLs For CGTs
10/16/2025
CGT developers face rising regulatory challenges around potency, stability, and process control. Find out how proactive planning, expert guidance, and early FDA engagement are key to avoiding delays.
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Creating A Compliant And Scalable CGT Logistics Launch Plan
6/12/2025
As cell and gene therapies advance to commercialization, biopharma companies face immense logistical hurdles. A customized, end-to-end strategy is crucial for ensuring product integrity and market success.
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Essential Guide To Post-Approval Regulatory Lifecycle Maintenance
4/14/2025
Understand the growing trend of outsourcing regulatory affairs in pharma, driven by expanding R&D pipelines and the need for specialized expertise to manage product lifecycles effectively.
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The Advantages Of Pharmacovigilance Outsourcing At The Local Level
4/14/2025
Outsourcing pharmacovigilance tasks can free up local teams for strategic work. Learn how to build effective partnerships by aligning needs, understanding capabilities, and fostering collaboration.
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Early Network Mapping To Guide HTA Literature Reviews
3/18/2025
How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.
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Advanced Aseptic Filling Technology And Annex I Compliance
1/2/2025
NIBRT's new isolator training facility in Dublin offers hands-on experience with advanced aseptic filling technology, addressing Annex 1 compliance and industry challenges in sterile drug manufacturing.
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Best Practices In The Design Of A Pharmaceutical Manufacturing Facility
11/6/2024
A well-designed manufacturing facility is critical to ensuring product quality and regulatory compliance. Let's examine the importance of the concept design review in achieving these goals.