Medical Writing
Formatting Automation

for Pharma Biotech

Manually formatting clinical documents to meet complex eCTD and agency-specific guidelines is tedious and prone to human error. Our automation solution standardizes styles, margins, tables, and references instantly, ensuring 100% submission-ready documents while freeing up medical writers to focus on science.

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 just as much as scientific review.
A document may have flawless data, but incorrect bookmarks or margins can still trigger agency
rejection.

Time-Intensive Work

Adjusting fonts, margins, headers, and footers across hundreds of pages eats into critical submission time that writers should spend on content.

Inconsistent Styles

Multiple authors collaborating on a single document often leads to broken styles, mismatched fonts, and irregular paragraph spacing.

Complex Guidelines

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

Broken Cross-References

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

Our Solution:
Intelligent Document Formatting

Our automated formatting tool 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.

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 medical writing and regulatory publishing by outputting files structurally primed for eCTD compilation.

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

By enforcing a strict style guide automatically, teams eliminate back-and-forth cycles between writers and publishers, accelerating time-to-market.

eCTD Ready Margins

PDF Bookmark Hierarchy

Cross-Reference Fixes

Automated TOC/LOF