Featured Insights

  1. The Crucial Role Of Scientific Regulatory Writing For Drug Approval 10/3/2024

    Scientific regulatory writing is a cornerstone of drug approval. Learn how crafting clear, accurate, and compliant documentation helps ensure timely and efficient submissions.

  2. Key Considerations For Data Strategies In The Pharmaceutical Industry 10/3/2024

    Navigating the complexities of data strategies in the pharmaceutical industry. Discover the key considerations and approaches to unlock the full potential of your data.

  3. Industry Insights In Isolator Technologies And Aseptic Processing In Pharma 8/30/2024

    Explore an overview of trends and insights in isolator technologies and aseptic processing in the pharmaceutical industry.

  4. Targeted Medicines: Enhancing Efficacy, Safety, And Regulatory Success 8/30/2024

    Learn about the importance of pharmacological considerations in the development and marketing of targeted medicines.

  5. What The Shift To The EMA's PMS Means For Industry 8/30/2024

    Explore the implications of the shift to the European Medicines Agency's Pharmacovigilance System Master File (PMS) database for the pharmaceutical industry.

  6. Balancing Customization And Standardization With Targeted Medicines 8/30/2024

    Examine an overview of the challenges companies face in handling regulatory differences when manufacturing targeted medicines.

  7. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.

  8. Key Steps To Harmonize Medical Device Software Machine Learning Best Practices 8/30/2024

    Explore a draft guideline from the International Medical Device Regulators Forum (IMDRF) on good machine learning practices for medical device software development.

  9. Understanding The impact Of The EU's Updated SoHO Legislation On ATMPS 8/30/2024

    Learn more about the updated EU legislation on substances of human origin (SoHOs) and it's significant implications for advanced therapy medicinal products (ATMPs).

  10. Navigating The Regulatory Maze Of Targeted Medicines 8/30/2024

    Learn more about the importance of early engagement with regulatory agencies and collaborating with experienced authorities to streamline the review process and enhance market access.