Discovery / Non-clinical
Post-approval / Maintenance
This paper highlights just a few key points that need consideration ahead of achieving and maintaining CMC Compliance in a more sustainable way.
Analysis of EMA's Product Management Services, the current Implementation Guide and future Development
This paper gives details on the background and recommended steps about the Analysis of EMA’s Product Management Services, the current Implementation Guide and future Development.
Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to: Level of Regulatory Affairs Involvement with M&A Programs, Increase market share by consolidating their product portfolio into specific therapeutic areas, Replenish their previously dwindling product pipeline, Enter into emerging markets with existing and new products, Reduce costs through the consolidation of manufacturing sites.