Featured Articles

  1. Plan For Your Extractables And Leachables Studies To Meet Submission Timelines

    Demonstrating the compatibility of any material in contact with drug product throughout its lifecycle (manufacture, containment, and delivery) is a necessity for a regulatory submission.

  2. Demystifying Performance Testing: Strategies To Qualify Combination Products

    Explore applicable regulations and guidances, and performance risks identified using failure modes and effects analyses (FMEA) and failure cause mapping analyses.

  3. The Path To Commercialization For Wearable Drug Delivery Devices

    Explore the evolution of the wearable drug delivery market, including the route to commercialization and the challenges faced.

  4. Early Decisions To De-Risk The Transition To Combination Products

    The injectable product development landscape is changing, and the pressure to accelerate timelines remains constant. What can you do to overcome all the uncertainty and risk?

  5. Is It Ever Too Soon To Start Your Performance Testing Assessment?

    Developing a safe and effective injectable combination product involves performing risk assessments, establishing a set of Critical Quality Attributes (CQAs), and performing design verification testing.

  6. Key Considerations For Selecting Fill/Finish Manufacturing Technologies

    Obtaining information and proactively mapping out your fill/finish strategy early can de-risk an investment in equipment or processes, ensuring you meet your long-term needs.

  7. Selecting A Vial Container Closure System With The DeltaCube™ Modeling Platform

    Understand a system approach that facilitates data-driven selection and optimization of vial container closure system components.

  8. Growing Complex Generic Application Load May Force US FDA Staffing Changes

    Staffing plans for complex generics and other FDA priorities may be complicated by the continual burden of the coronavirus pandemic. Learn what forced the agency to lower hiring and retention expectations earlier this year.

  9. Reliable Components For The Lifecycle Of Your Injectable Drug Product

    As drug products increase in complexity, become more specialized, and trend towards self-administration, it is more important than ever to have a reliable drug closure system.

  10. Indian Regulatory And Industry Bodies Call For Open Dialog With Policymakers

    Discover how the Indian Pharmaceutical Alliance saw regulatory bodies call for policy intervention to provide support and incentives for innovation and R&D in the Indian pharmaceutical sector.