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Process Validation for OTC Liquids and Topical Products

Process Validation for OTC Liquids and Topical Products

Presented by EAS Independent Consultant, Miguel Montalvo December 9-10, 2020 12:00–3:00pm Eastern If you manufacture OTC liquids, such as hand sanitizers, and other topical products, an effective Process Validation Program is an FDA requirement. Do you have a robust...
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 …