Resources

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...

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions...

Robust supplier quality agreements and good communication scheme can help avoid and alleviate regulatory concerns. Managing the relationships between clients and contract manufacturing organizations (CMOs) can be difficult as the...

A risk-managed approach to the global supply chain is more important than ever for life science manufacturers. The process is often easier said than done. It has been half a...

Q. I am a small-scale parenteral manufacturer and have been approached to support a clinical program through Phases II and III. What sterile manufacturing considerations are important for the small-scale...