Insights On Regulatory Compliance
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Annex 1 Compliance Guidelines For Biological Indicator Users
6/26/2023
Gain a deeper understanding of the requirements, guidelines, and best practices for Annex 1 compliance whether you're in pharmaceuticals, healthcare, or any field utilizing biological indicators.
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Increasing Automation To Transform CLD Workflows
8/1/2023
Advancements in cell line development workflows have created the potential for greater standardization and automation, eliminating the most common workflow bottlenecks and improving reproducibility.
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Navigating The FDA's Drug Supply Chain Security Act
3/14/2025
Explore the transformative impact of the DSCSA on the pharmaceutical industry, which ensures stringent standards, prevents counterfeit drugs, and enhances traceability for both large corporations and small manufacturers.
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ICH Guidelines: Challenges And Solutions For Pharma Manufacturers
10/8/2024
Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.
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Developing A Comprehensive Regulatory Approach For LNP Drugs
2/26/2024
The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.
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Tapping Into The Unexplored Through 505(b)(2) Pathway
10/9/2023
Leveraging the the 505(b)(2) regulatory pathway can enable an accelerated approval timeline and help advance your drug product to market. Review the three statutes that govern the approval pathways.
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Are You Aligned With FDA's Computer Software Assurance Methodology?
3/19/2025
Discover how Computer Software Assurance updates the FDA's Computer System Validation (CSV) framework to promise streamlined validation and cost reduction despite industry uncertainty.
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Accelerated Development: Gene Therapy Vs. Small Molecule
12/26/2023
Combined with the inherent difficulty of the chemistry behind gene therapy development, its pace, structure, and funding dynamics are unique among treatment modalities.
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Optimizing Cleaning And Disinfection As Part Of An Effective CCS
6/6/2024
Watch to explore the relationship between a Contamination Control Strategy (CCS) and the development of a robust cleaning and disinfection program for cleanroom environments.
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Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2
12/27/2024
Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.