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Selecting and Submitting an ANDA Application

Selecting and Submitting an ANDA Application

The FDA Generic Drug User Fees Amendment (GDUFA) has entered a relatively matured stage with applicants of Abbreviated New Drug Applications (ANDAs) experiencing a timely review and communications regarding their submissions packet, as well as increasing approval numbers. However, until an ANDA …

Your Source for Regulatory Pharma Support

Your Source for Regulatory Pharma Support

Meet With Us EAS is speaking at some of the most prestigious industry events: CHPA Regulatory Science & Quality Conference Sept 1-2, 2020 Washington, DC RAPS 2020 ConvergenceSept 13-16 2020Virtual Event Generis – American Pharma Outsourcing Nov 5-6, 2020 Boston,...
Writing Effective SOPs Can Influence Compliance

Writing Effective SOPs Can Influence Compliance

EAS independent consultant, Heidi Stuttz discussed how writing effective SOPs can influence compliance and build a better organization in Drug Development Delivery. Drug firms must devote time, diligence, and meticulousness in the development of safe product design, materials …