Regulatory Publishing
Automation

for Pharma Biotech

Document Publishing is important, and companies optimize this by best practices, outsourcing and some tools. Doesn’t matter what tools or vendors you use currently, probably most of the steps or activities are still largely manual. This may be leading to reworks, longer cycle times, people burn out, additional costs and frustrations. Whether your source files are in MS WORD or PDF, get submission ready files in minutes.

Schedule Demo

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Time & Cost Savings

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Rules Library

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Submission Ready

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Flexible Deployment Options

The Challenge: Limits of Traditional
Publishing

Even with outsourcing and existing tools, document publishing can be a bottleneck. Most steps
or activities remain largely manual, compromising speed and quality.

Longer Cycle Times

Manual alignment of elements, formatting, and standardizations cause unnecessary delays in critical submission timelines.

Reworks & Errors

Human interventions naturally lead to mistakes, forcing repetitive reworks and adding stress to regulatory teams.

Team Burnout

Constantly dealing with tedious validation and manual hyperlink updates creates significant frustration and team fatigue.

Additional Costs

The accumulation of delays, manual labor, and rework pipelines drive up overall publishing costs substantially.

Our Solution:
Efficient Automated Publishing

Our solution automates document publishing without disturbing your current eCTD infrastructure. It aligns to your current systems and processes by providing different options (local, cloud, plugins, integration).

With a deep 400 rules library, you pick and create your custom plans with the flexibility of applying what and when to your documents.

Word Plugins

Deploy seamless publishing checks directly within your MS Word environment.

Desktop / EDMS Uploads

Use our standalone tool to effortlessly upload and process files from your desktop or EDMS.

Batch Processing

Connect to existing Document stores and perform automated publishing on your schedule (hourly, daily).

Pre-Built Interfaces & Post-Publishing

We seamlessly integrate with your current eCTD systems, RIM, EDMS, ERP, SharePoint, Documentum, BOX, and other 3rd party Sources.
Once connected, you can automate validation with customized Dossier checks covering dossier elements, titles, and data/content level based on your specific checklists.
Easily create custom validation plans at the dossier level and selectively test validation paths for standard and custom dossiers.

Inter-Document Hyperlinks

Auto-Update File Names

Custom Validation Plans

Leaf Titles Update