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Delivering a Critical Vaccine:

How Document Conversion Saved the Day

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Overview

The clock was ticking for a top pharmaceutical company’s vaccine team. After a year of a compressed vaccine development timeline for a life-saving vaccine that held the key to solving a global public health crisis, the Global Vice President of Vaccines at a top pharmaceutical company came to Adlib in a panic.

With hours to go before the final step on their emergency authorization application for the U.S. Food & Drug Administration (FDA), the system crashed. And crashed again. The entire approval submission was in jeopardy.

Luckily, Adlib’s powerful document conversion software automated the process, working quickly and efficiently to create submission-ready PDFs that helped bring the vaccine to market within weeks.

Challenge

FDA approval requires documentation that details the meticulous research, impact, side effects, and administration instructions that make up the process of bringing a new vaccine to market. This generates massive amounts of information from distributed teams that need to be appropriately sorted and standardized for the application process

The team had to get this right. This life-saving vaccine held the key to solving a public health crisis, compressing a typical vaccine development from 5-10 years into one. Emergency authorization from the FDA meant the same amount of research but on a shorter timeline—with lives on the line.

With a hard deadline for emergency authorization, an atypical timeline, and an all-hands-on-deck approach to vaccine development, the vaccine team was feeling the pressure. They needed a way to make thousands of pieces of unstructured data like Word documents, spreadsheets, HTML files, images, and more streamlined and ready to submit to the FDA in easy-to-read PDFs. 

With only a few hours to go, their system kept crashing, putting the entire submission at risk.

Solution

After days of troubleshooting, the team turned to Adlib. They hoped the software was powerful enough to handle the submission volume and get it out the door. Now or never—it was worth a shot.

When the first document went through, a PDF conversion of several thousand pages, everyone breathed a sigh of relief—they had made it to the finish line.

Adlib’s powerful document conversion software transformed the rest of their data into submission-ready PDFs in less than an hour, delivering important medical information and application materials to the FDA in record time.

Document Conversion Made Easy

The pharmaceutical company installed Adlib and rendered files as large as 3,500 pages into approval-ready PDFs quickly and seamlessly. PDF conversion creates readable, submission-ready files that are:

  • Searchable
  • Hyperlinked
  • Bookmarked
  • ISO validated
  • Stamped with fully enriched metadata

All the team needed to make it happen was their existing documentation plugged into Adlib’s software. No data scientists, IT specialists, or Adlib team members needed. Just a streamlined, simple process that makes it fast and easy to bring new and life-saving medicines to market. The process was so seamless, in fact, that Adlib didn’t even know we saved the day until the submission was safely in the FDA’s hands.

FDA Compliance Simplified

Like all regulatory organizations, the FDA requires specific formatting, length, and information to evaluate approvals for new drugs and vaccines. With Adlib, the pharmaceutical company knew everything would be in the right format.

With all their t’s crossed and i’s dotted, the FDA had everything they needed to quickly approve the vaccine for emergency use, delivering it to first responders, high-risk patients, and healthcare workers within weeks.

Accelerate Time to Market with Adlib

When lives are on the line, your systems need to work. Adlib enables pharma and life sciences companies to accelerate time to market. Adlib simplifies the most complicated datasets and extracts valuable data from highly diverse and complex document formats. This allows pharma and life sciences companies to turn their unstructured data into premium, searchable PDF output with all the necessary navigation elements in it. You’ll never have to worry about overloaded systems or unreadable application files—Adlib’s document conversion software takes care of everything.