DocShifter

Can you imagine creating bookmarks in 600 files in just 2 days like this? (Yes, this happens more often than you think, especially if you are part of a Clinical Research Organization (CRO) or Regulatory Services provider.)

Almost everyone in the industry uses ribbons, plugins, desktop tools to format and prepare PDFs for submission-readiness.

There’s obviously nothing wrong with using these. Everyone in regulatory operations, or anyone responsible for formatting documents, is one way or another familiar with these solutions.

Here's the limitation, though: 1 document at a time. Whether the document contains 10 pages or 600 pages, this makes your job even more difficult. They are very ideal when you only want to work on a couple of pages, but not for a full submission.

3-click compliance with DocShifter is a much more efficient process. (I'll quickly explain.)

1. Select Word or PDF documents you want to include in a US FDA submission
2. Drop these documents in a web browser
3. Get FDA compliant output in a matter of seconds. With the correct bookmarks, hyperlinks, font settings, optimized for fast web view.

I call this 3-click compliance, but you can call it 'winning valuable time back', or 'my work has never been easier'.

Join our webinar on March 27 to find out more: https://eu1.hubs.ly/H0878zr0

If you are working for a Clinical Research Organization or a Regulatory Services provider, you probably recognize this dilemma.

If these companies could get 3 wishes from a jinn, they would most probably wish for:

1. Save time & resources
2. Do things faster
3. Reduce risks and increase the quality of the service to keep their customers happy.

Especially when preparing compliant content for their customers.

But, how? And where do you even start?

You do not have to experience this dilemma anymore. We talked about 3-click compliance in January, and how it can help pharma & biotech prepare submission content differently: faster, with much fewer risks involved.

This time, the spotlight will be on CROs and Regulatory Service providers. Discover how 3-click compliance (yes, literally 3 clicks) will:

1. Take your compliant document preparation from hours to just seconds
2. Help you remain compliant without sacrificing quality
3. Help you stay ahead of the competition
4. Minimize the headache of dealing with different PDF & other content specifications for your customers.

Looking forward to seeing you in our webinar. And as always, bring your questions and comments with you to the session: https://eu1.hubs.ly/H07_Dwp0

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has standardized how health authorities should receive PDF files.

In addition, some regions demand PDFs with slightly different specifications.

Different PDF requirements; formatting rules; navigation elements.
That is the name of the game when dealing with multiple health authorities.

These renditions can be automated when dealing with global submissions,

DocShifter takes your source documents and creates compliant versions for each region, all with the right navigation-elements, PDF properties, table of contents, and everything else.

No more late nights fixing PDFs or stressing about compliance: whether you need to replace existing source documents, or manipulate it to meet the health authority requirements.