FEATURED ARTICLES

• Is FDA's COVID Container Closure System Guidance Useful Post-Pandemic?

  The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.

• Navigating The Marketing Authorization Process In Europe
• Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities
• Understanding And Delivering Your EU Orphan Drug Launch
• Autologous Cell Therapies At Crossroads With FDA: What To Do Now?

WHITE PAPERS & CASE STUDIES

• Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

  Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.

• Enhancing Process Safety In The Pharmaceutical Industry

  This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.

• Security Of Pharmaceuticals: A Comparison Of EU And US Standards

  Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.

• Improving Quality Processes For Medical Device Development And Manufacturing

  Organizations that consistently develop and launch new products efficiently in an environment of increasing regulatory scrutiny, successfully manage regulatory risk. By Mike Kuehne, ACSYS, Inc.

• Selecting, Implementing, And Using FDA Compliance Software Solutions

  We begin by asking the question, “Is the Quality Management Software market evolving to be easier, or more complex?”

• eTMF And The eClinical Universe

  How Electronic Trial Master Files (eTMFs) Work With Other eClinical Systems To Help You Meet Regulatory Requirements.