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Medical Device Quality Auditing

Medical Device manufacturers understand the tight FDA regulations and legal obligations surrounding devices. From initial safety and effectiveness study design through Pre-Market Applications (PMAs), Pre-Market Notifications (PMN), registration, Good Manufacturing Practices (GMPs) through reporting …

An Overview of Drug Master Files

An Overview of Drug Master Files

DMFs are regulatory submissions to FDA for drug substances, drug products, and/or container closures allowing FDA to review information such as confidential details about facilities, processes, components, or articles used in the manufacturing, processing, packaging, and …

EAS Webinar Replays Available for Viewing

Two new webinar replays have been added to the EAS Consulting Group website under the Events tab. We hope that you find these webinars informative. Should you have any questions, please reach out to Senior Director for Food Consulting Services, Allen Sayler....

EAS Webinar on the Role of Your US Agent

EAS Senior Director for Pharmaceutical and Medical Device Consulting Services, Bryan J. Coleman and Regulatory Specialist, Victoria Pankovich will co-present an EAS webinar on the Role of Your US Agent in a webinar February 27, 2018, at 10:00 am eastern. Join us to...