Challenge: The US Subsidiary of a Large, International Pharmaceutical Company Needed Assistance in Preparing for Several Regulatory Inspections

Beaufort Solution: A majority of the company’s clinical and regulatory staff had never participated in a regulatory inspection and anxiety levels were running high. Beaufort began the project by interviewing all pertinent personnel to establish its experience level and determine the company’s preparedness for the inspections. Our work included extensive document reviews, mock audits, extensive training sessions, both seminar and one-on-one. Beaufort also developed white papers to share with regulatory authorities during the inspections. We developed a series of mock inspections and follow-up activities, and the client passed all regulatory inspections with minimal audit findings, including a major FDA pharmocovigilance inspection.

Date posted: September 9, 2011

Categories: Case Studies Clinical Research Quality Assurance & Compliance