Aug 29, 2024 | EAS in the News Drugs
In an interview with Pharma Commerce Editor Nicholas Saraceno, Jeb Hunter, Senior Regulatory Consultant, EAS Consulting Group, discusses the on “What to Expect When They’re Inspecting: FDA Inspections on DSCSA Compliance” breakout session at the 2024 HDA...
Jul 3, 2022 | Cosmetics, Dietary Supplements, Drugs, EAS in Action, EAS in the News Cosmetics, EAS in the News Dietary Supplements, EAS in the News Drugs, EAS in the News Medical Device, EASeNews, Medical Devices
EAS Consultant, Tamika Cathey, is featured in Tablets and Capsules magazine with an article on establishing an effective environmental monitoring program. Contamination is costly, with recalls and fines for problematic products in the hundreds of millions. EAS offers...
Apr 25, 2022 | Dietary Supplements, Drugs, EAS in Action, EAS in the News Dietary Supplements, EAS in the News Drugs
EAS Independent Consultant and expert in packaging solutions for FDA industries, Jim Goldman, wrote an article on quality considerations and mitigations of supplier and customer challenges that was published in Tablets and Capsules. EAS experts such as Jim help...
Aug 10, 2021 | Drugs, EAS in the News Drugs
EAS independent consultant, Radhika Rajagopalan answers your questions on DMF submissions in Tablets and Capsules magazine. Under the Generic Drug User Fees Act (GDUFA), the FDA applies a holistic, life-cycle approach to the evaluation of active pharmaceutical...
Jul 29, 2021 | Drugs, EAS in the News Drugs
By Amy Scanlin Reprinted with permission from FDLI Update Good Manufacturing Practices—those minimum requirements for methods, facilities, and controls used in manufacturing, processing, and packing of drug products.1 Though clearly articulated by FDA, a review of FY...
Jan 1, 2021 | Drugs, EAS in the News Drugs, EAS in the News Medical Device, Extra Article, Medical Devices
EAS published an article in MedTech Intelligence on the importance of component GMP requirements for drug-device combination products. “The rapid development of combination products—biologics, pharmaceuticals and their devices—provides great opportunity for...
