How CROs & Regulatory Service Providers save time in preparing compliant PDFs
with 3-click automation

Search Results for: FDA compliant PDF

How do you deal with track changes in Microsoft Word when converting to PDF?

Track changes and comments don’t look consistent when you convert Microsoft Word documents to PDF?

Are you having trouble converting Microsoft Word documents containing track changes and comments to PDF? Creating consistent output when converting MS Word documents containing track changes into PDF is a big challenge. With multiple reviewers and authors working on the same document, each with their styling, getting this consistency is almost an impossible mission.  Do […]

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What is the role of data in regulatory submissions? Is the role of data, taking over the role of PDF in electronic submissions in life sciences?

Is data taking over the role of PDF in eCTD submissions?

The Life Sciences industry is dedicated to protecting the health of millions of individuals worldwide. The industry is also looking to improve their lives with affordable and easily accessible medicinal products. Patient and patient safety always comes first, which is why the process of bringing a drug to the market takes many years (from 8

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‘Achieve Document Compliance Earlier in Submissions’ — What does this even mean?

If you ever attended one of our webinars, you will have heard us say this a lot. But, what do we actually mean by ‘achieve document compliance earlier’? It is actually a pretty simple concept. Instead of validating the PDF files for compliance with the submission itself (after the draft publishing stage), why not create

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Navigating the Regulatory Submission Process

Regulatory submissions are a very critical milestone in the life sciences industry. They are literally the translation of (mostly) 10 years’ worth of R&D work into success.  Therefore, navigating regulatory submissions is a critical and often complex hurdle.  The regulatory submissions process involves 5 main stages, being: Pre-submission Application preparation Submission & review Addressing deficiencies

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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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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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DocShifter Automation in Microsoft SharePoint Use Case Page

Are you using Microsoft SharePoint to store & manage your submission content? ​Add powerful conversion capabilities to your Microsoft SharePoint environment. Take submission document preparation automation to the next level. Automatically check & fix Word & PDF files for compliance Generate submission-ready PDFs from various formats Automate report compilation from binders or ZIP files Trigger

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DocShifter Automation in OpenText Documentum Use Case Page

Are you using OpenText Documentum to store & manage your submission content? ​Combined with the power of DocShifter, take submission document preparation automation to the next level. Automatically check & fix Word & PDF files for compliance Generate submission-ready PDFs from virtual documents Automate report compilation from virtual documents or ZIP files Trigger automation in

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Dynamic Scalability in Document Conversion: What is it?

In today’s digital age, organizations are generating and handling an unprecedented amount of digital documents in various file formats. From invoices and reports to contracts and customer records, the need to convert documents from one format to another is an everyday requirement. However, managing the conversion process efficiently is challenging, especially when faced with fluctuating

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