Blogs
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Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework
5/8/2024
Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.
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Getting The CAPA Framework Right The First Time
5/8/2024
CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.
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EMA’S eCTD 4.0 Workshop Seeks To Gear Industry For Implementation
4/12/2024
As the EU prepares to implement the new eCTD 4.0 standard for regulatory submissions, the European Medicines Agency (EMA) is taking steps to ensure a smooth transition for industry.
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Key Takeaways From The ISPE Ireland Annex 1 Event
4/12/2024
Key insights from the ISPE Ireland Annex 1 Event shed light on challenges and solutions in meeting EU GMP guidelines for sterile medicinal products.
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Handling Substantial Modifications Under The CTR
3/15/2024
The transition of ongoing clinical trials to meet CTR requirements can be challenging. Examine some key considerations, including substantial modification processes and strategic dossier updates.
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A Comparative Guide To CGTs: Modalities, Landscape, And Logistics
2/29/2024
Cell and gene therapies (CGTs) have the potential to revolutionize medicine. However, achieving therapeutic success requires advanced logistical consideration to ensure product safety and efficacy
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Overcoming The Complex Logistics Of Autologous Cell Therapy Trials: A Deep Dive Into Challenges And Solutions
12/8/2023
Explore critical logistical requirements in autologous cell therapies logistics and learn how to overcome challenges and achieve successful and timely autologous cell therapy trials.
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A Blueprint For Genuine Partnership In TMF Improvement
12/5/2023
Embrace the evolving significance of Trial Master Files by fostering strong partnerships, as exemplified in this collaborative model designed to optimize management and strengthen organizations.
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Rewind The Clock And Take TMF Back To Basics
12/4/2023
Consider the evolution of Trial Master Files (TMF) in clinical trials when tackling the paradigm of maintaining simplicity while embracing technology.
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Crafting An Effective Commercialization Strategy For CGTs
10/25/2023
Patient access and manufacturing efficiency persist as barriers to widespread adoption of CGTs. An effective commercialization strategy is crucial to expand access to these life-changing therapies.