Best practices in
compliant PDF preparation
compliant PDF preparation
Discover real-life examples on
bookmarks
hyperlinks
table of contents
PDF optimization & many more
PharmaLex, a technology-enabled solution provider for pharma & biotech companies, uses DocShifter to accelerate compliant PDF conversion of submission content.
Ensuring confidence beyond compliance with DocShifter
employees
1
+
documents / month
1
clients worldwide
1
offices in 24 countries
0
Reducing manual work, and the associated costs & risks
PharmaLex, a technology enabled solution provider in the Life Sciences industry, has chosen DocShifter to speed up and automate the preparation of submission-ready PDF documents for their 1000 clients worldwide.
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 rationalise the tools used, and 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.
The DocShifter impact
saved per document, across thousands of documents processed monthly.
1
minutes
saved thanks to DocShifter every year.
1
hours
implementation time from test to production.
months
"The business case was compelling."
Quality
"The quality and reliability of DocShifter is very good. The integration with our submission management system makes it seamless to generate submission-ready PDFs, and the volume of PDF features eliminates most of our manual work."
Cost
"We took a simple approach to the business case: If we could save five minutes on every document processed, multiplied by the number of documents and multiplied again by the hourly rate of a pre-publisher, that could give us a figure that we could balance against the cost of implementing a DocShifter solution. The business case was compelling."
Responsiveness
"DocShifter is a friendly and flexible company, they are passionate about their product and provide a service that really shows they care about our success.
We have had some specific requirements for creating submission-ready PDF renditions. DocShifter listened to all of our comments and suggestions and have incorporated the majority of them into the recent releases. The speed of making these changes has been very impressive."
"DocShifter will save us over 750 hours of manual work per year. And we expect the time savings to increase as we continue to expand our use of DocShifter.
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
This is significant for our clients who need the eCTD sequences to be published quickly, accurately and efficiently. "
Jennie May - Director, Regulatory Operations
PharmaLex - Confidence beyond compliance
