Medical Writing
Formatting Automation

for Pharma Biotech

Manually formatting clinical, CMC, Labeling and regulatory documents to meet external eCTD and agency-specific guidelines or your internal rules/SOPs is tedious and prone to human error. Our automation formats using 350+ rules library instantly, ensuring submission-ready documents while freeing up resources and time by over 70%.

Schedule Demo

DDi-pharma-mw-formatting-automation_mock

0%

Reduction in Formatting Time

0%

eCTD Compliance

0

Manual Style Adjustments

21

CFR Part 11 Compliant

The Challenge: Limitations of Manual Formatting

At DDi, we know that technical formatting delays submissions. A document may have flawless data, but incorrect formatting can still trigger QC failures, extra reworks or sometimes agency rejection.

Time-Intensive Work

Adjusting tables formatting, finding hidden text, alignments and other document formats across hundreds of pages eats into critical resource time that should b freed uo.

Inconsistent Styles

Multiple authors collaborating on a single document often leads to broken styles, mismatched fonts, copy/pasting issues, and irregular paragraph issues.

Complex Guidelines

Adhering to strict corporate templates, SOPS, along with global ICH and eCTD formatting requirements manually, is difficult and heavily error-prone.

Broken Cross-References

Updating tables of contents, lists of figures, and internal hyperlinks manually often results in broken or incorrect navigation.

Our Automated Solution (REGai):
Document Formatting Library and Agents

Our automated formatting platform instantly applies pre-defined corporate and regulatory style guides to your Word documents. From generating accurate Tables of Contents to standardizing table layouts and fixing broken links, the platform ensures technical compliance without the manual hassle. Deploy as Word Plugins or do as Batch performing on multiple files in 1 go

Instant Style Application

Ensure documents align with corporate templates and specific regulatory expectations in one click.

Automated Restructuring

Instantly fix margins, fonts, spacing, and page orientations that would take hours manually.

Dynamic Linking

Automatically generate correct TOCs, Lists of Tables/Figures, and repair broken in-text references.

Submission Readiness

Formatting automation goes beyond aesthetics. It bridges the gap between authors and regulatory publishing by outputting files structurally primed for internal requirements as well as eCTD compilation.

Our solution ensures everything from exact page numbering formats to proper PDF bookmarking hierarchy is flawless upon conversion.

By this automation, teams eliminate back-and-forth cycles between writers and publishers, accelerating time-to-market.

eCTD Ready Margins

Bookmark Hierarchy

Table issues

Automated TOC/LOF