Compliant, submission-ready PDFs for multiple health authorities. Without any manual work.

Converting multiple source documents into technically compliant PDFs for eCTD submissions can be a hassle.

With DocShifter’s PDF+ software, leading Life Sciences organizations are accelerating their regulatory submissions. How? By automatically rendering documents into compliant PDFs. For 1 or multiple health authorities all in 1 go.

From FDA and PMDA, to Health Canada and EMA submissions (plus many more) – with hundreds of configuration options, DocShifter's PDF+ can handle the most demanding of health authority technical requirements.

Do you recognize these challenges?

Convert documents into submission-ready PDF documents for PMDA, EMA and other health authorities

Too many regulations & too little time

Time to market is key for any Life Sciences company. The patients' health is at stake. Few industries face the same level of regulatory complexity. Tight timelines and different compliance requirements across the globe require strict processes and tools to support them. The right technology is fundamental in ensuring success.

EMA, FDA, PMDA, etc. have specific technical PDF requirements

Each global regulator has similar, but slightly different requirements. While the same content can be reused, the final PDF needs to be different (e.g. bookmark levels set, PDF version, etc.). Automating this PDF preparation process to ensure the right requirements are used is critical. You do not want to do this manually.

Using multiple tools to generate submission-ready PDF documents for regulatory submissions is expensive

Using multiple tools is expensive

From submission content preparation to eCTD submissions, many organizations still rely on multiple, siloed desktop tools (such as MS Office and Adobe technology) – causing high IT infrastructure and licensing costs. By syncing into a single solution, companies can avoid time-to-market delays and stem financial losses.

Manually manipulating PDFs is risky

Using desktop tools to manually handle PDF content is an error-prone task. Embedding fonts, checking hyperlinks, adding ToCs and setting zoom-levels on links and bookmarks to ensure health authority compliance all too often becomes time-consuming. Get it wrong, however, and it can cost a lot more than just your time.

The solution?

Fully searchable, compliant PDF renditions. Create what the regulators demand. Without the manual work.

DocShifter’s PDF+ solution is a document-to-PDF conversion software with compliance at its core, generating submission-ready renditions for multiple health authorities (including FDA, EMA, PMDA, Health Canada, Swissmedic and many more).

DocShifter takes all of your source files from your RIM or DMS and automatically converts them into compliant PDFs. It provides hundreds of configuration options to ensure you can meet the most demanding of health authority technical requirements.

Our goal? To facilitate an easy submission. Whether you submit to 1 or more health authorities. Without the human intervention.

Live Webinar + Practical Demo on
June 8, Thursday at 9AM PST, 12PM EST, 17 UK, 18 CET

Is your submission content preparation too slow? manual? complex? time-consuming?

Live Webinar on August 31st |
2 sessions in 1 day

Discover how you can automate

Rendering Veeva binders into consolidated, compliant PDFs

Report generation by merging multiple documents into PDF

Word and PDF submission content validation

Live Webinar + Practical Demo on July 31st | 2 sessions in 1 day

Is your report compilation too slow? manual? complex? time-consuming?

Benefit from a confidently compliant submission-ready PDF solution

Avoid eCTD validation errors

Achieve technical document compliance before submission publishing

Focus more on the content, and not on formatting

Reduce risk with preconfigured PDF compliance settings for all Health Authorities

Save time and money with DocShifter’s one-and-done setup and automations

Generate uniform, high quality compliant PDF output

Automated and compliant submission-ready PDF conversion

A powerful, extremely fast and easy to use PDF conversion software solution, designed to improve your compliant document transformation process

Partnering with confidence

PharmaLex, a technology-enabled solution provider in the Life Sciences industry, partnered with DocShifter to streamline their complex PDF-submission process for their 1000+ clients worldwide. So what changed?

5 minutes

saved per document

750 Hours

saved per year

Serving 1000

customers with 1 solution

DocShifter NV - Eedverbondkaai 242/003 B-9000 Gent Belgium - hello@docshifter.com

Compliant, submission-ready PDFs for multiple health authorities. Without any manual work.

Do you recognize these challenges?

Too many regulations & too little time

EMA, FDA, PMDA, etc. have specific technical PDF requirements

Using multiple tools is expensive

Manually manipulating PDFs is risky

The solution?

Fully searchable, compliant PDF renditions. Create what the regulators demand. Without the manual work.

Is your submission content preparation too slow? manual? complex? time-consuming?

Discover how you can automate

Rendering Veeva binders into consolidated, compliant PDFs

Report generation by merging multiple documents into PDF

Word and PDF submission content validation

Is your report compilation too slow? manual? complex? time-consuming?

Benefit from a confidently compliant submission-ready PDF solution

Avoid eCTD validation errors

Achieve technical document compliance before submission publishing

Focus more on the content, and not on formatting

Reduce risk with preconfigured PDF compliance settings for all Health Authorities

Save time and money with DocShifter’s one-and-done setup and automations

Generate uniform, high quality compliant PDF output

Automated and compliant submission-ready PDF conversion

Partnering with confidence

How does DocShifter work?

Discover our life sciences knowledge hub

Report Generation Automation with DocShifter (with a practical demo)

Regulatory Professionals Community on LinkedIn

Free FDA PDF format specifications checklist

Discover why 6 out of 10 of the world’s leading pharmaceutical companies trust DocShifter to generate compliant PDFs for their regulatory submissions

Website

Use Cases

Solutions

Resources

Follow Us

Contact Details

Compliant, submission-ready PDFs for multiple health authorities. Without any manual work.

Do you recognize these challenges?

Too many regulations & too little time

EMA, FDA, PMDA, etc. have specific technical PDF requirements

Using multiple tools is expensive

Manually manipulating PDFs is risky

The solution?

Fully searchable, compliant PDF renditions. Create what the regulators demand. Without the manual work.

Is your submission content preparation too slow? manual? complex? time-consuming?

Discover how you can automate

Rendering Veeva binders into consolidated, compliant PDFs

Report generation by merging multiple documents into PDF

Word and PDF submission content validation

Is your report compilation too slow? manual? complex? time-consuming?

Benefit from a confidently compliant submission-ready PDF solution

Avoid eCTD validation errors

Achieve technical document compliance before submission publishing

Focus more on the content, and not on formatting

Reduce risk with preconfigured PDF compliance settings for all Health Authorities

Save time and money with DocShifter’s one-and-done setup and automations

Generate uniform, high quality compliant PDF output

Automated and compliant submission-ready PDF conversion

Partnering with confidence

How does DocShifter work?

Discover our life sciences knowledge hub

Report Generation Automation with DocShifter (with a practical demo)

Regulatory Professionals Community on LinkedIn

Free FDA PDF format specifications checklist​

Discover why 6 out of 10 of the world’s leading pharmaceutical companies trust DocShifter to generate compliant PDFs for their regulatory submissions

Website

Use Cases

Solutions

Resources

Follow Us

Contact Details

Free FDA PDF format specifications checklist