Moonbay Technology - Pipeline RA

Cloud Computing for Regulatory Affairs

PIPELINE RA combines a company-wide central repository for all regulatory documentation and data with an eCTD publisher to provide our clients with a "one-step" solution for eCTD submissions.

Additional Benefits:

Pipeline RA is ideal for Regulatory Affairs because SaaS applications are run on the cloud computing model meaning the applications are hosted and do not require installation of additional software and servers.

Pipeline RA clients can view the submission building process in real time and provide more control over the content that is submitted to the Agency.

Pipeline RA clients can use this cloud-based solution and build submission in-house or outsource the submission and still maintain control over the content and the submission.

Cloud computing can reduce the risk of a hardware failure or loss of data during a critical submission.

Document Management Features
7 Integrated Modules*	Research, Nonclinical, Chemistry/Manufacture/Controls (CMC), Quality Assurance, Clinical, Product Safety, Regulatory
Reference Library	Central repository for literature references
Service Portals	Secure portals for information transfer
Message Board	Automatic notifications, recurring reminders, and message archival
Regulatory Submissions
eCTD Building	eCTD building based on current specifications
Regulatory Correspondence Management	Tools to manage correspondence to and from Regulatory Agencies

*Modules in PIPELINE RA follow the Reference Model being developed by the DIA’s SIAC(non-profit) for standards for document management.