With the knowledge to help you anticipate what’s coming next, the infrastructure and processes to help you adapt, and the integrity to provide intuitive insights, our quality and regulatory compliance teams stand ready to support your development and manufacturing process.
Our Approach to Regulatory Compliance
Drawing on more than 20 years of delivering life-saving, life-extending therapies to the market, Emergent CDMO is an attentive partner for your drug program - from program kick-off through final product shipment, and every milestone in between. Our compliance team is here to support your regulatory targets with respect to cGMP manufacturing activities, whether it is onsite customer audits or regulatory agency inspections.
Our goal is to provide transparent and proactive communications with our customers in anticipation of regulatory agency requirements and by employing continuous improvement philosophies. This allows us to be inspection ready at all times, and so provide timely responses to regulatory authority questions, requests, and observations concerning manufacturing services. This commitment can extend to support the drafting and review of documentation for regulatory dossiers.