PharmaLex, a leading provider of specialized services for the pharmaceutical, biotech and medical device industries, chose DocShifter to simplify and accelerate the generation of compliant, submission-ready PDF documents for their 1000’s of clients worldwide. 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.
DocShifter is a proven document conversion and validation solution for pharmaceutical, biotech and medical device companies. The software automates, accelerates and simplifies the way companies create submission-ready PDFs from original source documents; no matter which system these documents reside in. DocShifter 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 realize real, immediate and lasting benefits for our clients.” said Jennie May, Director of Regulatory Informatics & Operations at PharmaLex, with 20 years of experience in the industry.
More and more life sciences companies are adopting DocShifter’s document conversion and validation solutions to automate and speed up the way they approach submission content preparation. DocShifter’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 increases operational efficiency in regulatory and beyond, with one centralized 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.
DocShifter’s focus remains on helping life sciences companies accelerate compliant document conversion, and PharmaLex, a technology enabled solution provider, has benefited greatly from this focus in a short period of time.
“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 from PDF source documents. Docshifter listened to all 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.” said Jennie May.
“Our future plans are simple. We will remain focused on what we do best: making file format conversion easy. While doing so, we will stay close to our customers, and make sure we always continue to exceed their expectations” said Geert van Peteghem, CEO at DocShifter. “This will bring us even closer to our customers, and become one of the major players when people think of compliant PDF conversion in Life Sciences.”
For more on what DocShifter can mean for Life Sciences, visit: https://www.docshifter.com/industry/life-sciences/
Speed, quality, scalability and configurability are reasons why leading Life Sciences companies select DocShifter to convert documents into high quality, navigation-rich, searchable PDF and PDF/A documents, amongst many other formats (Word, e-mail, audio, video, TIFF, JPG, Excel, HTML, XML, etc.). High volume, high quality document conversion, on premise or in the cloud. Simple to set up. Automate. Centralize. Eliminate manual intervention. Reduce risk of non-compliance. Reduce IT infrastructure costs.
DocShifter provides compliant, fast, automated and scalable file format conversion for pharmaceutical, biotech and medical devices companies.
PharmaLex is a leading provider of specialized services for the pharmaceutical, biotech and medical device industries. We offer a wide range of services essential to enable companies to maximize their development process and reduce their time to market. We guide companies from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post launch activities. Our experts use technology-enabled solutions to support clients through the entire product lifecycle. PharmaLex delivers exceptional results – going above and beyond the standard to deliver tailor-made solutions worldwide. The PharmaLex Group now has over 1700 employees, with 45 offices in 24 countries and more than 1000 satisfied clients worldwide. For more information, visit https://www.pharmalex.com/
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