If done properly, labeling begins at the earliest stages of development, as soon as the results from market analysis and expected scientific outcomes become available. As product development advances and the regulatory team begins preparation of the FDA submission, the Sales and Marketing team should begin preparing promotional materials for DDMAC review, to be delivered once FDA approvable is received. All promotional materials, including the product label, are scrutinized by the regulatory department, research development, legal, and often senior management. Revisions are frequently requested and readdressing data is common.
MasterControl can help automate the process of collaboration and redlining of promotional documents, and, once a decision is a made, obtaining the necessary approvals to move the promotional documents from their virtual "draft" vault into a virtual "release/approved" vault.
Pharmaceutical GxP Process Automation
MasterControl automates pharmaceutical GxP processes to improve efficiency and speed time to market. Processes include: