Post by DDReg Pharma Pvt. Ltd.

Most combination product failures aren't science failures. They're classification failures, and they happen before a single regulatory submission is made.   Wrong centre determined. Wrong dossier prepared. Notified Body consultation initiated 18 months too late. Post-market obligations are misattributed between drug and device frameworks.   The cost isn't just a resubmission. It's a reset.   PMOA determination, EU drug-device dossier structure, and Notified Body coordination timelines are decisions that need to be made at the start of development, not after a reviewer flags them.   Full breakdown on where classification errors materialise and what early engagement actually changes.   Explore more: https://lnkd.in/d4BPUY-v   #CombinationProducts #RegulatoryAffairs #DrugDevelopment #MedicalDevice #FDA #EMA #CDER #CDRH #MDR #DDReg #LifeSciences