PharmaLex taps DocShifter for PDF generation

Published: 11-Jan-2022
Regulatory Digital

DocShifter is a document conversion and validation solution for pharmaceutical, biotech and medical device companies

PharmaLex, a service provider for the pharmaceutical, biotech and medical device industries, has chosen DocShifter for the generation of PDF documents for its client base. PharmaLex's services include document pre-publishing and regulatory submission publishing, therefore managing large numbers of documents in different formats and differing levels of quality is a high priority.

DocShifter is a document conversion and validation solution for pharmaceutical, biotech and medical device companies. The software is designed to automate, accelerate and simplify the way companies create submission-ready PDFs from original source documents; no matter which system these documents reside in. According to the company, the software can automatically validate the PDF output against health authority requirements, fix errors and return a report to ensure compliance.

"Our clients need their eCTD sequences to be published quickly, accurately and efficiently. Our aim is to go above and beyond in delivering compliance solutions, by combining existing state-of-the-art software and our established know-how, and DocShifter fits perfectly into our strategy. DocShifter saves us a lot of time (on average, we estimate 5 minutes per document, multiplied by thousands of documents), reduces the risk of non-compliance, increases the quality of PDF renditions; allowing us to realise real, immediate and lasting benefits for our clients," said Jennie May, Director of Regulatory Informatics & Operations at PharmaLex.

The company says its software’s flexibility to connect with multiple systems, check and fix Word and PDF documents and simultaneously generate submission-ready PDF documents for multiple health authorities improves operational efficiency in regulatory and beyond, with one centralised platform.

"Working with PharmaLex has been a great experience. I've known them for a while, and they have always been known for delivering exceptional services. We are very happy we can contribute to PharmaLex living up to the promises they make to their customers." says Paul Ireland, VP Life Sciences at DocShifter.

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