Electronic Submissions (eSub) and FDA CFR Part 11 Compliance
The inability to effectively manage the complex documentation necessary to satisfy regulatory compliance and achieve product approval is a major factor in slowing down the time it takes to bring a new product to market. These delays cost companies hundreds of thousands of dollars in potential lost revenue. At MAJARO InfoSystems, Inc., our staff has numerous years of e-submission expertise and experience. Our SAS®-based ClinAccess™ system accepts documents in virtually any electronic format. CRF images and SAS® data sets can be prepared in FDA ready format, efficiently and reliably.
We proudly provide all areas of document processing and publishing, including scanning, bookmarking, and hyper linking of data. MAJARO InfoSystems, Inc. staff can provide the technical guidance and regulatory expertise necessary to fully support the preparation of electronic regulatory submissions, in compliance with FDA 21 CFR Part 11 and CDISC guidelines.
We can help you create an entire eSub or provide specific relevant components. Whether we are engaged to support a specific deliverable or to manage the production of an entire submission, our specialists will work with your clients to make the transition from paper to electronic submissions as painless as possible.
Submission Types:
- NDA
- BLA
- SNDA
- CTD
- ANDA
- IND
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