Resources

Q: I am a regulatory professional working for a small company with a product in the early stages of development. Can you tell me when I need to submit the...

Q: Companies have made a lot of operational changes to accommodate working through the pandemic. What changes do you think will become permanent in FDA inspection procedure as a result...

Learn more about remote inspections, FDA inspection training and begin preparing now for next year’s FDA remote inspections. “Physical inspections, especially when unannounced, are one of FDA’s most important tools...

Q. I have heard that the International Council for Harmonization’s (ICH’s) Q9 Quality Risk Management is being revised. Do you know what the industry can expect to see with the...

Getting the most value out of Mergers or Acquisitions requires proper upfront legwork, risk management and risk assessment. In the business press, discussions of mergers and acquisitions (M&As) invariably include...

The long awaited, anxiously anticipated FDA guidance on quality metrics was finally distributed on July 28, 2015. Its official title is "Request for Quality Metrics, Guidance for Industry" and its...