Pipeline RA Provides Solutions for Regulatory Affairs
We submit our information in paper. Electronic submissions are complicated. Why change?
Along with the many business reasons to submit electronically, the FDA strongly encourages electronic submissions. In addition to speeding up the product review process, electronic submissions lend credibility to your organization and provide cost savings over time. While the FDA has not set a date for an electronic submission mandate, they continue to move in that direction and expect to mandate electronic submissions within three to five years. Moonbay Technology can help your organization easily transition your regulatory submissions from paper to electronic.
We are required to submit Establishment Registration and Product Listing electronically. How can we do this without the appropriate technology in house?
We can help you to prepare and submit product and establishment registration required by the FDA for products to be marketed in the United States. Our value added is that Pipeline RA manages and versions the content that goes into the submission allowing for a quick turn-around time for updates.
Our submission vendor only creates submissions, but we have no system for controlling the content that goes into the submission.
Regulatory Affairs need more than just a tool to crank out submissions. The content that goes into the submission must be carefully managed so that the content can be reused making faster processing times for future submissions. Additionally, correspondence must be carefully managed so that communication between you and the Agency can made clear, especially when meeting with the Agency to discuss your products.
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