Publishing Audit Readiness: Evidence Package US Inspectors Expect for eCTD Operations in 2023 Publishing Audit Readiness: Evidence Package US Inspectors Expect for eCTD Operations in 2023 As the biopharmaceutical landscape continues to evolve, regulatory compliance in electronic Common Technical Document (eCTD) submissions has become increasingly rigorous. This guide will navigate you through the essential steps to prepare your eCTD publishing services for audit readiness by US inspectors in 2023. We will cover everything from initial dossier preparation to ensuring that your documentation meets current FDA expectations, making it easier to achieve compliance. Step 1: Understanding the eCTD Framework Before delving…