Featured Insights
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Understanding The UK's International Recognition Procedure
3/18/2025
The UK's International Recognition Procedure (IRP) streamlines market access for medicines. Learn how its targeted assessments foster quicker approvals and innovation.
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What The Inspectors Want: A Guide To TMF Inspection-Readiness
3/18/2025
Regulatory authorities expect sponsors to maintain proper TMF oversight. This article outlines strategies for inspection readiness, risk-based reviews, access control, and best practices for successful compliance.
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Three Key Takeaways From The PDA Annex 1 Workshop
3/17/2025
Annex 1's impact on sterile manufacturing was dissected at PDA's Dublin workshop. Regulators stressed risk management, centralized control strategies, and the value of personnel knowledge.
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Collaboration, Local Knowledge Key To The Nordic Pharmaceutical Market
3/17/2025
Companies looking to tap into the Nordic pharmaceutical market must recognize the unique blend of shared values and individual regulatory landscapes that define its unique approach to healthcare.
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Best Practices For Agnostic Document Processing In The TMF
3/17/2025
Explores best practices for agnostic document processing in the Trial Master File (TMF), with insights on how to streamline workflows and enhance productivity.
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Evolving And Expanding Global Consulting With Local Expertise
2/3/2025
Experts discuss global market expansion, emphasizing regulatory complexities, product lifecycle investments, and integrating local expertise to ensure successful product launches and long-term market sustainability.
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Legal Changes To Fortify Environmental Risk Assessment Of Pharmaceuticals
2/3/2025
A new EU directive may require stricter environmental risk assessments for pharmaceuticals, impacting marketing authorization. Updated guidelines already in effect pose new challenges for companies.
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The Digital Pharmaceutical Journey: 2025 And Beyond
2/3/2025
By 2025 and beyond, AI, structured data, and real-world evidence will reshape the landscape, driving personalized medicine and more efficient processes. Here are eight key trends to watch.
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Topic Sterility Assurance With Noelle Clifford
2/3/2025
Sterility assurance requires robust programs from raw materials to facility design. Learn about best practices, misconceptions, and the importance of environmental monitoring and regulatory compliance.
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Leveraging RWE To Support Market Access Decision-Making
1/17/2025
Real-world evidence (RWE) is changing how new medications are evaluated for market access. Experts offer insights into how RWE informs payer decisions and product positioning.