DocShifter

24/12/2024

🎄 𝐇𝐚𝐩𝐩𝐲 𝐇𝐨𝐥𝐢𝐝𝐚𝐲𝐬 𝐟𝐫𝐨𝐦 𝐚𝐥𝐥 𝐨𝐟 𝐮𝐬 𝐚𝐭 𝐃𝐨𝐜𝐒𝐡𝐢𝐟𝐭𝐞𝐫🎄

This year has been filled with exciting milestones, industry recognition, meaningful partnerships, and moments of pure joy that remind us why we do what we do at DocShifter.

From joining forces with Ennov to sharing smiles over Tintin comic books across conferences, each highlight and experience has shaped where we’re headed.

Here’s a look back at the highlights that made 2024 unforgettable for DocShifter.

This year has been filled with exciting milestones, industry recognition, meaningful partnerships, and moments of pure joy that remind us why we do what we do at DocShifter. From joining forces with Ennov to sharing smiles over Tintin comic books across conferences, each highlight and experience has

03/04/2024

A warm thank you to everyone that made our '3-click document compliance for CRO & Regulatory Service providers' a success last week. Thank you for your questions and interaction.

There were multiple questions about bookmarks.

To be more specific, whether it is possible to automatically create a bookmark structure in PDFs where no bookmarks are present in the source document.

With DocShifter, the answer is yes.

Here is a short video from our 3-click document compliance webinar; showing you the:

- how
- what
- results

Go for a much faster, efficient PDF preparation process for your regulatory submissions.

16/03/2024

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

14/03/2024

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

12/03/2024

Can you imagine creating bookmarks in 600 files in just 2 days like this? (Yes, this happens more often than you think.)

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.

What is a more efficient way, though?

3-click compliance with DocShifter. (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'.

Check out more on our latest LinkedIn article: https://eu1.hubs.ly/H07_Dwm0

28/02/2024

I was chatting with a Reg Ops manager at a mid-size pharma company about efficiency improvements for their submissions in Veeva. She was facing a dilemma.

"Look, we need to be compliant AND hit those submission deadlines. To meet technical compliance guidelines, we have a lot of manual work. And with all the manual work, we put our submission deadlines at risk. The manual work has to stop! But how?"

Seriously, right? Is this how it has to be?

Spoiler alert: NOPE! There is a choice.

On Feb 29th, we organise a webinar on how you can save valuable time when creating compliant documents in Veeva with the help of DocShifter software.

📌 Webinar info: https://eu1.hubs.ly/H07QB-20

P.S. Do you have the same struggle? Let me know in the comments.

25/01/2024

Who's Paul Ireland for the 3-click compliance session next week?
And no, 3-click is not a buzzword.

Here's an example I will be talking about during the session.

1. Select Word or PDF files to be included in your US FDA submission
2. Upload these to DocShifter via a web browser
3. Get FDA compliant, navigation-rich PDF results back.

OR

1. Choose the Word or PDF files you wish to inspect and correct for non-compliance elements.
2. Upload these to DocShifter via a web browser.
3. Get the fixed Word & PDF files back in no time.

That's where the 3 clicks come from.

Preparing PDFs, reports, or any other content can really be this easy. You do not need to spend hours manipulating PDFs on desktop tools.

Would you like to know or see more? Join Paul Ireland to learn how in our exclusive webinar on January 30.

See you there?



https://eu1.hubs.ly/H07b3Wz0

17/01/2024

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.

11/01/2024

🚨 Good news for medical device manufacturers!🚨

The U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has transitioned from paper to electronic export documents for medical devices.

This change streamlines the process for manufacturers, reduces processing times, and minimizes environmental impact.

Read the full article here: https://eu1.hubs.ly/H06Zt1S0

21/12/2023

Happy New Year, DocShifters 🎉

As the year winds down, we want to take a moment to express our deepest gratitude to our amazing customers. You're the reason we love what we do!

Together, we've shifted mountains of documents, streamlined workflows, and unlocked new levels of productivity. Thank you for trusting us, and for being such a fantastic partner in conquering document chaos.

11/12/2023

Hours, days, weeks and maybe months?

How much time are you spending preparing the exact same documents for global submissions?

Is there a more efficient way of doing it?

Imagine taking the same source documents and preparing an FDA, EMA, PMDA, Health Canada, MHRA version all in one go, with as little manual work as possible.

This approach significantly accelerates your time to market when submitting to one or multiple health authorities simultaneously.

Join us on December 14th as we discuss this in detail. Looking forward to seeing you on Thursday.

Save your spot here in just 5 seconds: https://eu1.hubs.ly/H06BsDH0

27/11/2023

"𝘖𝘶𝘳 𝘵𝘦𝘢𝘮 𝘴𝘱𝘦𝘯𝘥𝘴 𝘩𝘢𝘭𝘧 𝘰𝘧 𝘵𝘩𝘦𝘪𝘳 𝘵𝘪𝘮𝘦 𝘤𝘩𝘦𝘤𝘬𝘪𝘯𝘨 𝘢𝘯𝘥 𝘧𝘪𝘹𝘪𝘯𝘨 𝘗𝘋𝘍𝘴 𝘧𝘰𝘳 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯-𝘳𝘦𝘢𝘥𝘪𝘯𝘦𝘴𝘴: 𝘣𝘰𝘰𝘬𝘮𝘢𝘳𝘬𝘴, 𝘻𝘰𝘰𝘮 𝘭𝘦𝘷𝘦𝘭𝘴, 𝘩𝘺𝘱𝘦𝘳𝘭𝘪𝘯𝘬𝘴, 𝘧𝘰𝘯𝘵𝘴, 𝘗𝘋𝘍 𝘷𝘦𝘳𝘴𝘪𝘰𝘯, 𝘵𝘦𝘹𝘵-𝘴𝘦𝘢𝘳𝘤𝘩𝘢𝘣𝘪𝘭𝘪𝘵𝘺, 𝘧𝘰𝘯𝘵 𝘴𝘪𝘻𝘦𝘴, 𝘴𝘵𝘺𝘭𝘪𝘯𝘨, 𝘵𝘢𝘣𝘭𝘦 𝘰𝘧 𝘤𝘰𝘯𝘵𝘦𝘯𝘵𝘴, 𝘢𝘯𝘥 𝘮𝘰𝘳𝘦…

𝘈𝘭𝘭 𝘵𝘩𝘪𝘴 𝘮𝘢𝘯𝘶𝘢𝘭 𝘸𝘰𝘳𝘬 𝘪𝘴 𝘴𝘦𝘳𝘪𝘰𝘶𝘴𝘭𝘺 𝘥𝘦𝘭𝘢𝘺𝘪𝘯𝘨 𝘰𝘶𝘳 𝘴𝘶𝘣𝘮𝘪𝘴𝘴𝘪𝘰𝘯𝘴. 𝘌𝘴𝘱𝘦𝘤𝘪𝘢𝘭𝘭𝘺 𝘸𝘩𝘦𝘯 𝘸𝘦 𝘩𝘢𝘷𝘦 𝘵𝘰 𝘴𝘶𝘣𝘮𝘪𝘵 𝘵𝘰 𝘮𝘶𝘭𝘵𝘪𝘱𝘭𝘦 𝘩𝘦𝘢𝘭𝘵𝘩 𝘢𝘶𝘵𝘩𝘰𝘳𝘪𝘵𝘪𝘦𝘴."

I have heard this from at least 10 different regulatory operations managers, working for top pharmaceutical and biotech companies.

And my answer has always been the same: 𝐀𝐮𝐭𝐨𝐦𝐚𝐭𝐢𝐨𝐧 𝐢𝐬 𝐩𝐨𝐬𝐬𝐢𝐛𝐥𝐞 𝐭𝐨 𝐬𝐚𝐯𝐞 𝐭𝐡𝐞 𝐝𝐚𝐲.

Join us for the latest insightful webinar of 2023. Paul Ireland will show you how you can significantly reduce the manual work when preparing and formatting PDFs for global submissions, and accelerate time to market.

Save your spot here: https://eu1.hubs.ly/H06nBFW0

We look forward to seeing you in one of our sessions on December 14th!