Liquent Regulatory Solutions for Life Sciences

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The FDA Compiler, a key component of Liquent's submission publishing suite, automates output to meet specific requirements from the Food and Drug Administration (FDA) for electronic submissions.

An extension of the Liquent CoreDossier solution, the FDA Compiler structures the submission output to meet specific FDA requirements with three modules:

• CBER Module - Center for Biologic Evaluation and Research
• CDER Module - Center for Drug Evaluation and Research
• Data Associator - enables attachment of SAS data sets required by CDER and CBER

Our team of regulatory experts works proactively with the FDA to ensure that these solutions meet the agency's expectations. We continuously review and comment on the guidances to gain insight into their future direction.
Whether filing electronic new drug applications (NDAs) with CDER or electronic biologic license applications (BLAs) with CBER, the FDA Compiler makes the process even more efficient by maximizing the power of CoreDossier.

The FDA Compiler streamlines the submission process through:

• Comprehensive support for CDER's NDA and CBER's BLA guidances on making electronic submissions
• Support for DMS metadata mapping to automatically fill in required PDF document information fields
• Automatic generation of correct hierarchy of file and folder names
• Alerts when file sizes exceed FDA regulations
• Automation of Item 11 datatocs and define pdf files

Automatic time-saving features:

• Creation of required three-column tables of contents including correctly formatted hyperlinks
• Creation of full-text search indexes for appropriate sections
• Automated generation of cross references to create the desired "massively hyperlinked" submissions