PharmaLex provides document pre-publishing and regulatory submission publishing services for multiple clients and therefore receives large numbers of documents in a variety of formats and quality. The documents are a mixture of Administrative (Cover Letter, Application form), Summaries, Quality, Non-Clinical and Clinical content.
PharmaLex was previously using licensed PDF plug-in tools to prepare content for inclusion in submissions. The process of converting the original source documents to fully compliant submission-ready documents was complex, manual and extremely time-consuming.
Due to the volume (thousands of documents every year) and complexity (different document sizes, multiple formats such as Word, PDF, scanned PDF, etc.) of documents, the PharmaLex team has decided to streamline and rationalize the tools used. There was also feedback from the publishers that preparing submission-ready documents was time-consuming and resource intensive.
PharmaLex also had a difficult time in predicting time, cost and quality for planning and resourcing, as they had no control over the quality of the submission documents they received from their customers.
The Solution
To simplify, accelerate and automate the submission-content preparation process, PharmaLex team decided to make the switch to DocShifter.
DocShifter works directly with PharmaLex’s submission management system, picks up the original source documents, creates the compliant PDF renditions (simultaneously for either one, or multiple HAs), and uploads the compliant PDFs back into the submission management system, ready for compiling into the submission publishing tool.
This allows the PharmaLex team to avoid resource intensive tasks, save time on the critical path, reduce cost, reduce the risk of non-compliance, and provide better and faster document publishing services. All while maintaining essential quality and compliance.
Reasons for Choosing DocShifter and the benefits
The PharmaLex team was able to overcome the challenges by seamlessly integrating DocShifter with their submission management system.
Listen from Jennie May, the regulatory operations director at PharmaLex, what the benefits of using DocShifter were to streamline submission-ready PDF documents.
