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.
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.
According to PwC, some large pharma companies have reported as much as 40% of their spend will be
subcontracted and that their clinical operations functions will eventually be entirely outsourced.