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.

• The Case For A Facility Monitoring System

  Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits.

• 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.

• The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA

  The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.

• Exceeding GMP Of Medical Devices At Each Step In The Production Continuum

  Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.