Insights On Regulatory Compliance

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.