Keep Production Thriving in a Highly Regulated Environment

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 25 years of delivering our own portfolio of life-saving, life-extending therapies to the market, Emergent Bioservices 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 to 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.

Timely, Effective Quality Management

At Emergent, we are passionate about providing high-quality drug process development and manufacturing for your therapeutic or vaccine. Our focus on continuous improvement helps define our quality management operations, which provides a foundation for our quality policies, standards, and well-defined SOPs.

Our experienced QC, QA, validation, and document control teams actively adhere to phase-appropriate cGMP standards. Quality by Design (QbD) is applied to all processes, from early development through commercialization, and our sourcing and procurement teams maintain a broad base of cGMP qualified vendors.

Regardless of your initial program goal, our goal remains the same: Provide responsive regulatory compliance support and high-quality services.