Resources

If the FDA’s recent finalizations of Good Manufacturing Practices for Combination Practices has left you uncertain about regulation changes, listen in on our webinar on Combination Products: Lessons Learned on...

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...

A pharmaceutical start-up with a novel drug approached RCA to design its shipping validation study. RCA developed multiple studies based on the company's complex transportation, product stability, and packaging needs....

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...

In the business press, discussions of mergers or acquisitions (M&A) invariably include percentages of deals that did not realize their expected value creation. Failure numbers, ranging from 60-80 percent, are...

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...