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Search Results for: Regulatory submission software

Submission-ready PDF

Submission-ready PDFs for multiple health authorities Full eCTD compliance without any manual work Create what the regulators demand: fully searchable, compliant PDF renditions See DocShifter in action Main Menu Benefits Solution How? Challenges Contact Us FAQ Benefit from a confidently compliant submission-ready PDF solution Automated validation across multiple regions Compatible with all regions, including USA, […]

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eCTD 4.0: Key Changes & Impact on Submission Content Preparation

Following our previous “What’s next after eCTD?” article, this paper aims to provide a brief update on the next major version of eCTD, version 4.0. Since 2003, eCTD has been adopted by an increasing number of Health Authorities around the world. The standard has evolved incrementally in that time. eCTD 4.0 will introduce significant updates

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PharmaLex speeds up their customers' submissions and content preparation thanks to DocShifter's automated submission-ready PDF conversion capabilities

Pharma time-to-market reduced thanks to more efficient submission document publishing services

  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

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How to reduce content creation issues in regulatory submissions?

How to reduce regulatory content creation issues? 4 tips.

Life Sciences organisations are required to create huge quantities of documentation to support the marketing of their products around the world. Industry standards have been put in place to ensure that Global Health Authorities receive content in a manner that simplifies the review and approval process of new medicines or devices. These guidelines do provide

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Frequently asked questions on the eCTD format (Part 1)

Frequently asked questions on the eCTD submission format (Part 1)

This article answers the most frequently asked questions on the electronic common technical document submission format. A regulatory submission for a Healthcare or Life Sciences product includes all sorts of documentation and information that is submitted to a regulatory agency for: review notification or in response to a request for additional information What are the

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The impact of Automated Report Generation for A Large Medical Devices Company

Automated Report Level Publishing for 510k and PMA Submissions for a Medical Devices Company No more manually merging Microsoft Word files into PDF reports 1 employees 1 documents / month 1 $ annual revenue The Challenge Related to Manual PDF Report Generation The company traditionally used manual methods to compile PDF documents for regulatory submissions

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DocShifter Automation in Ennov Use Case Page

Are you using Ennov to store & manage your submission content? Combined with the power of DocShifter, take submission document preparation automation to the next level. Generate fully-compliant submission-ready PDFs from your documents Automatically check & fix Word & PDF files for compliance Automate report compilation from document collections Fully automated PDF manipulation Trigger advanced

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Life Sciences

Accelerate your compliant document preparation. One solution for all your regulatory and other content transformation needs. Pharma & Biotech Medical Devices CRO Services Trusted by life sciences companies of all sizes Committed to delivering the best document conversion/validation software in Life Sciences. Pharma & Biotech Use one solution for all your regulatory and other content

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3 Click Compliance: What does it mean? How does it work?

Before we introduce what 3 click compliance is, let’s quickly reveal the technology behind it. The technology that makes it possible to significantly speed up and simplify the way you prepare content for submissions today. DocShifter Express. What is DocShifter Express (DS Express)?   DocShifter Express is a browser-based platform that simplifies and streamlines various

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