Electronic Submissions and Regulatory Publishing

PRA's Regulatory Publishing group submits electronic regulatory submissions that are fully compliant with current guidelines. Our Publishing team works closely with PRA’s Medical Writers, Biostatisticians and Programmers, and external contributors to ensure successful and on time submissions. To accomplish this, we:

• Review final documents for content, formatting and consistency
• Coordinate and manages the compilation of submission components
• Publish the submission
• Review the final product for quality control and assurance

We perform:

• Complete eCTD (electronic common technical document) submissions and other marketing application formats
• Individual components of a submission (e.g. study reports)
• eCTD submission life-cycle management activities: appending and replacing files in current eCTD submissions or subsequent amendments

The United States and several European Union countries currently accept the CTD in electronic format. Additionally, the EEA, Japan, Central and Eastern European States are moving in this direction. With many more countries coming on board with electronic submissions, planning and utilizing electronic regulatory submissions is integral to success in today’s market.

Rapid Electronic Regulatory Submissions

The heart of PRA's Electronic Publishing system is Liquent's InSight Publisher – an industry standard electronic system that enables the assembly, management and publication of complex documents that constitute the regulatory submission. Built specifically with eCTD format in mind, InSight Publisher is designed to publish submission material that is compliant with the guidelines and requirements of all regulatory agencies that accept the ICH eCTD specification. InSight Publisher also provides a centralized global view of product details, documents, and submissions to support collaboration and eCTD lifecycle management.

Additionally, PRA uses Image Solutions ISI ToolBox to create submission-ready documents, including Case Report Forms that are bookmarked and hyperlinked to regulatory agency specifications. Combined with our high speed Xerox Nuvera and D240 printers, PRA has everything our clients need to create submission-quality documents, reports and applications.