Paper CTD to eCTD Conversion
Full conversion of legacy paper or scanned CTD dossiers (Modules 1–5) into structured, searchable eCTD format. Includes OCR processing, PDF optimization, and XML backbone creation for FDA, EMA, or CDSCO submissions.
The Common Technical Document (CTD) is a standardized format for pharmaceutical regulatory submissions. While paper-based CTDs were once the norm, global regulatory authorities — including the US FDA, EMA, and CDSCO — now mandate or strongly prefer submissions in electronic CTD (eCTD) format, which is structured, searchable, and lifecycle-managed.
CTD to eCTD conversion involves restructuring existing paper or digital dossiers into the XML-based eCTD format, complete with proper backbone structure, technical validation, and sequence management — ensuring full compliance with regional and international guidelines.
A structured, quality-driven workflow ensures your converted eCTD dossier is accurate, validated, and submission-ready on the first attempt.
We audit your existing CTD dossier to identify structural gaps, missing data, and compliance issues before conversion begins.
All source documents — PDFs, Word files, study reports — are formatted, hyperlinked, and bookmarked per ICH eCTD specifications.
We build the XML backbone and folder hierarchy compliant with ICH M8 guidelines for the target regulatory authority.
The eCTD package is validated using approved validation tools (e.g., Lorenz, Certus) to detect and resolve errors before submission.
We submit the validated eCTD to the regulatory authority and provide ongoing lifecycle management for amendments and renewals.
MedWisdom Lifesciences offers end-to-end eCTD conversion and publishing support tailored to your product type, target market, and regulatory authority.
Full conversion of legacy paper or scanned CTD dossiers (Modules 1–5) into structured, searchable eCTD format. Includes OCR processing, PDF optimization, and XML backbone creation for FDA, EMA, or CDSCO submissions.
Conversion of digitally compiled CTD dossiers (Word, PDF) that lack the proper eCTD structure. We reorganize, hyperlink, and publish them into a fully compliant, lifecycle-ready eCTD sequence.
eCTD packages customized for specific authorities: FDA (USA), EMA (EU), CDSCO (India), Health Canada, TGA (Australia), GCC countries, and more — each with region-specific Module 1 administrative sections.
Independent technical validation of your existing or newly prepared eCTD using industry-standard validation tools. We identify and resolve structural, hyperlink, and XML errors prior to regulatory submission.
Ongoing management of your eCTD lifecycle including sequence updates for amendments, supplements, Type I/II variations, post-approval changes, and renewal submissions — ensuring continuity and compliance throughout your product's regulatory history.
Pre-conversion gap assessment against current ICH CTD/eCTD guidelines to identify missing documents, outdated data, or non-compliant formatting — with a clear remediation plan before submission.
Understanding the key differences helps pharmaceutical companies make informed decisions about upgrading their regulatory submissions.
| Criteria | Paper / Legacy CTD | Electronic CTD (eCTD) |
|---|---|---|
| Submission Format | Physical binders or unstructured PDFs | XML backbone with structured, hyperlinked PDFs |
| FDA/EMA Compliance | ✗ No longer accepted by FDA/EMA | ✓ Mandatory for US & EU submissions |
| Lifecycle Management | ✗ Manual, error-prone updates | ✓ Automated sequence management |
| Reviewer Processing | Slow; requires manual document navigation | Fast; fully searchable and hyperlinked |
| Multi-Regional Submissions | ✗ Requires separate full dossiers per region | ✓ Single master dossier, region-specific Module 1 |
| Approval Speed | Longer processing due to format limitations | Faster approvals with compliant, validated submissions |
| Post-Approval Changes | Full resubmission of affected sections | Incremental sequence updates only |
With deep regulatory expertise and a quality-first approach, MedWisdom delivers eCTD conversions that minimize risk, reduce timelines, and accelerate product approvals.
Our specialists have hands-on expertise with ICH M2/M8 eCTD guidelines and have prepared and converted dossiers for FDA, EMA, CDSCO, Health Canada, and GCC authorities.
We use industry-standard eCTD authoring and validation tools (Lorenz, Certus) to ensure every submission package passes technical validation on the first attempt.
We understand that regulatory timelines are critical. Our project management approach ensures milestones are met without compromising quality or accuracy.
Every converted dossier undergoes multi-level QC review — content check, structural validation, hyperlink testing — before it reaches your desk or the regulatory authority.
We offer competitive, transparent pricing tailored to your dossier scope — no hidden charges. Get a detailed quote before work begins, with no surprises at delivery.
Our relationship doesn't end at submission. We provide responsive support for agency queries, deficiency responses, and lifecycle sequence updates throughout your product's regulatory journey.
Our eCTD conversion services are designed to meet the specific regulatory requirements of diverse product categories and industries.
Quick answers to the most common questions about our CTD to eCTD conversion services in India.