Insights On Regulatory Compliance

31. Emulate Endorses The FDA Modernization Act Of 2021 5/10/2024

    Learn why removing the mandate for animal testing would enable faster, more efficient, and more humane drug development, all while benefiting both patients and the pharmaceutical industry.

32. Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services 6/26/2024

    Gain insight into the mobile cleanroom that was created to accommodate the needs of Moffitt Cancer Center's Oncology Infusion Pharmacy Services and adhere to USP <797> and <800> standards.

33. How To Navigate The EU HTA Regulation For Better Market Access 10/21/2024

    The EU's new Health Technology Assessment Regulation poses challenges and opportunities for the biopharma industry, making manufacturers adapt to unpredictable PICOs and prioritize scenario planning.

34. Compressed Gas Risk Assessment: A Significant Step In Your CCS 10/10/2024

    Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

35. Do You Have an FDA Audit Process in Place? 2/23/2023

    Ease the stress of a U.S. Food and Drug Administration (FDA) visit to your facility by learning how to maintain a state of FDA audit process readiness.

36. Streamlining The Integrity Testing Process – From Test To Report 2/22/2023

    Discover a digital transformation solution that provides first of its kind data analytics for filter integrity testing. The software helps operators and supervisors reduce time lost through review processes.

37. FDA Recall Prevention: Save Time, Money, And Reputation 10/8/2024

    FDA product recalls pose significant challenges for life sciences companies. Avoid recalls with these actionable steps to mitigate risk, ensure compliance, and safeguard your organization's reputation.

38. Partnering On An Innovative Hydrogel-Based Treatment For Glioblastoma 3/22/2023

    Treatments for glioblastoma multiforme (GBM) are in high demand. Learn more about the new possibilities for increased dosing and diffusion capabilities offered by nanoformed APIs.

39. 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.

40. Key Takeaways Of Annex 1: What It Means For Your Cold Chain Management 10/19/2023

    What are the practical implications of the latest Annex 1 update, specifically for cold chain management?