Insights On Regulatory Compliance

  1. Re-Engineering A Complex Process For FDA Compliance 8/21/2024

    Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

  2. Key Takeaways From The ISPE Aseptic Processing Seminar 4/14/2025

    How is the pharmaceutical industry increasing aseptic processing safety? An ISPE event showcased innovations like robotics and improved risk management, aligning with recent regulatory guidance.

  3. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  4. Overcoming Challenges In Ophthalmic Formulations 8/27/2025

    Discover key strategies for overcoming formulation challenges in ophthalmic drug development and learn how selecting the right excipients supports quality, compliance, and safety.

  5. Validation Provider Shortens The Path To Equipment Qualification 8/19/2025

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  6. Unlock Oncology Success With A Comprehensive Commercialization Guide 8/22/2025

    Navigate the complex process of bringing an oncology therapy to market, from regulatory planning to patient access and supply chain logistics, with this comprehensive handbook for developers.

  7. Navigating The Regulatory Space To Biosimilar Approval 9/1/2025

    The biosimilar patent cliff is reshaping pharma, creating unprecedented opportunities for biotech and CDMOs. Explore expert regulatory support that can help you navigate this shift with confidence.

  8. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

  9. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  10. A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk 10/10/2024

    Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.