On The Precipice Of An Impending Avalanche Of Regulatory Compliance Activity: Are You Prepared?

The COVID-19 pandemic highlighted vulnerabilities in medical product supply chains and emphasized the urgency of ensuring their integrity for patient access. It accelerated the development and production of COVID-19 tests, treatments, and vaccines, prompting regulatory flexibility but potentially compromising manufacturing and testing facility oversight. Key developments include measures to mitigate viral spread at facilities, disruptions to on-site regulatory inspections, increased use of virtual assessments by health authorities, broader Emergency Use Authorizations (EUA), and improved tracking of facility quality management maturity (QMM).

Understand why proactive compliance is crucial as regulatory bodies adapt inspection strategies, emphasizing the importance of maintaining high-quality standards amidst evolving regulatory landscapes, by reading the full article below.