TRANSITIONING FROM PAPER TO ELECTRONIC 2253 SUBMISSIONS
TRANSITIONING FROM PAPER TO ELECTRONIC 2253 SUBMISSIONS
1 Pageswww.rednucleus.com contact us at info@rednucleus.com Case Study R&D 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 h
