TRANSITIONING FROM PAPER TO ELECTRONIC 2253 SUBMISSIONS

Client Challenge

Several pharmaceutical companies (from small to large) have proactively started the process of transitioning their 2253 process from paper to electronic in anticipation of the FDA requirements for electronic submissions.

Red Nucleus Solution

The Red Nucleus team worked with the client’s Ad Promo Ops, Marketing, and Regulatory Operations Publishing functions to establish the new process and standards for transitioning the company from 2253 paper submissions to electronic (CD) and/or eCTD submissions. Our R&D Operations team also provided subject matter experts (SMEs) and comprehensive outsourced eCTD processing capabilities.

Value

Red Nucleus has developed customized strategies for each client looking to transition to electronic 2253 submissions. We help clients build internal capabilities that are optimized for efficiency and compliance. Our R&D Operations team also offers these complete capabilities as an outsourcing option. Several clients have transitioned and used both services.