Services
[ Therapeutic Expertise ] [ Trials Management Services ] [ Early Development Services ] [ Late Phase Services ] [ Drug Safety Management ] [ Electronic Regulatory Submissions ]
Electronic Regulatory Submissions
Regulatory support is crucial to all phases of the
drug development process, and PRA is dedicated to
serving as your regulatory partner with total commitment
to the success of your development program. Our focus is
to expedite the regulatory review process and shorten
drug development timelines through innovative thinking
and uncompromising quality.
Why Electronic Regulatory
Submissions?
Regulatory agencies are rapidly moving toward
requiring submissions in electronic format and in many
instances are currently requesting electronic
submissions. Electronic submissions allow regulatory
reviewers to rapidly and efficiently search and navigate
marketing applications and other submissions,
facilitating and potentially shortening the time to
approval. Data can be readily accessed, allowing
reviewers to run additional analyses without having to
request these analyses from the sponsor. Large paper
submissions, comprising hundreds of binders and
requiring extreme shipping methods, will no longer be
necessary in many countries.
The United States and several European Medical
Evaluations Agency (EMEA) countries currently accept the
CTD in electronic format. Additionally, the EEA, Central
and Eastern European States are also moving in this
direction. With many more countries, including Japan,
coming on board with electronic submissions, budgeting
for electronic regulatory submissions is integral to
success in today’s market.
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 (electronic common technical document) format in mind, InSight Publisher is designed to publish submission
material that is compliant with the guidelines and requirements of regulatory agencies globally 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 you need to create submission-quality documents, reports and applications.
PRA Global Regulatory Publishing
PRA Global Regulatory publishers bring regulatory
expertise to provide electronic regulatory submissions
that are fully compliant with current Agency guidelines.
This group reviews final documents for content,
formatting and consistency; coordinates and manages the
compilation of submission components; publishes the
submission; and reviews the final product for quality
control and assurance.
Working in close conjunction with medical writers,
biostatisticians and programmers throughout PRA as well
as other external contributors, this group is
responsible for the complete published submission and
its delivery to the regulatory agency.
Page last updated:
20 June 2008
|
