Submission
Management

for Pharma and Medical Devices

Regulatory operations and submission management involve compiling, preparing, publishing, validating, and archiving the critical documents required by global health authorities and notified bodies.

Whether you are bringing a groundbreaking drug to market or launching a life-saving medical device, navigating complex
regulatory landscapes demands speed, precision, and absolute compliance.

DDi’s Visu platform unifies and accelerates the end-to-end dossier lifecycle for the pharmaceutical, biotech, and medical device industries. By combining robust content management with AI and automation workflows, we eliminate manual bottlenecks, reduce cycle times, and ensure first-time-right submissions.

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The Core Pillars of Our Solution

1. Document Collection & Automated Ingestion

Managing submissions requires collecting massive amounts of documentation from diverse internal and external teams.

Automated Ingestion:Seamlessly connect with your existing EDMS, clinical, or quality systems to extract source documents (Word, PDF, data streams).
AI-Powered Format Automation: Our platform automatically scans documents for compliance with regional health authority standards. It self-corrects and flags errors – running automated Quality Control (QC) to auto-fix formatting, fonts, margins, hyperlinking, and bookmarks, ensuring documents are submission-ready instantly.

2. Content Preparation & Technical Verification

Avoid manual editing and tedious formatting review loops.

Document Intelligence: The tool utilizes natural language processing (NLP) to verify consistency across regulatory texts, labeling, and summaries.
Pre-submission Validation: Automatically check content against specific health authority guidelines (such as FDA, EMA, or PMDA) and medical device validation rules before compiling the final dossier.

3. Comprehensive Lifecycle Management

A submission doesn’t end with the initial approval.

Continuous Updates: Seamlessly manage lifecycle events, including variations, amendments, supplements, safety updates, and device-label changes.
Traceability Matrix: Maintain granular visibility at both the document and correspondence level. Always understand exactly which document version is tied to which regional submission.

4. Global Compliance & Standards

Stay ahead of evolving regional mandates without manual overhead.

Pharmaceutical Formats: Native support for the International Council for Harmonisation (ICH) eCTD (Electronic Common Technical Document) specifications.
Medical Device & IVD Regulations:Purpose-built workflows supporting the unique structures required for EU MDR, EU IVDR, STED (Summary Technical Documentation), and FDA 510(k), PMA, and De Novo pathways.
Internal Governance:Align submissions with your internal rulebooks and standard operating procedures (SOPs).

5. Collaborative Project Management

Break down silos between cross-functional teams.

Unified Workspace:Enable secure collaboration among Regulatory Affairs, Quality Assurance, Clinical Development, Medical Affairs, and device engineering teams..
Built-in Workflows Ensure everyone meets their milestones with visible timelines, task assignments, and real-time dashboard tracking.

Dossier Build & Publish

One Platform. Any Country. Absolute Compliance.

DDi enables you to seamlessly build, view, validate, and archive compliant submissions for standard country
formats as well as regions with highly specific, non-standard custom requirements.

Pre-built Publishing Plans

Leverage country-specific configurations for rapid setup.

Template Management

Create and customize structured submission plans using reusable templates tailored to specific drug or device classes.

Cross-Country Linkages

Eliminate duplicate efforts by linking core data and master dossiers across multiple regional submissions.

Multi-Format Outputs

Compile and publish outputs exactly as required by the regulator – including XML (eCTD), structured PDFs, Zip archives, or specialized medical device portfolios.