Expert Quality Assurance consulting and auditing services for GMP, GCP, GLP, and PV.
We will implement the necessary measures to safeguard your reputation for quality both now and in the future.
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The release of the ICH Guideline for Good Clinical Practice (E6 R2) in November of 2016 has, for the first time in over a decade, put new guidelines and regulations in front of clinical trial...Continue Reading
For drug and device manufacturers in the United States, electronic records created through computerized systems must be maintained in accordance with FDA’s 21 CFR Part 11 and EudraLex Volume 4 Annex...Continue Reading