Remote Regulatory Assessments – Q&A: Here to Stay
Blog Post

Remote Regulatory Assessments – Q&A: Here to Stay

On January 26, 2024, the Food and Drug Administration (FDA) provided notification of a revised draft guidance on Remote Regulatory Assessments (RRAs).  The FDA has...

Read More
EU & US MRA Fully Operational – What You Need to Know!
Blog Post

EU & US MRA Fully Operational – What You Need to Know!

Background In 1998, the EU and the US signed a broad Mutual Recognition Agreement (MRA), which included a Pharmaceutical Annex providing for anticipated and limited...

Read More
How to Measure PQS Effectiveness Using the CAPA System
Blog Post

How to Measure PQS Effectiveness Using the CAPA System

A ICH Q10 Challenge   (more…)

Read More