Accelerate regulatory submissions and variation updates with governed, modular content.
Chemistry, Manufacturing, and Controls (CMC) documentation plays a critical role across the product lifecycle—from initial filings through post-approval change management. Yet traditional document-based approaches are slow, siloed, and risk-prone.
Docuvera replaces manual, file-based processes with a governance-first structured content platform. By enabling modular authoring, upstream data integration, multilingual output, and continuous compliance, we help pharma organizations manage global CMC content with confidence and speed
Integrate Upstream Data from Source Systems
Support PQ-CMC standards and FHIR-based interoperability.
CMC content doesn’t start at the document—it starts at the data source. Docuvera ingests content from upstream systems such as:
- Laboratory Information Management Systems (LIMS)
- Manufacturing Execution Systems (MES)
- CMO and CDMO document portals
- Stability and analytical data repositories
Structured components are aligned to PQ-I and PQ-CMC frameworks, version-controlled, and tracked for auditability. With support for FHIR (Fast Healthcare Interoperability Resources), Docuvera enables standards-based data exchange across manufacturing and regulatory systems.
Bringing CMC Content into the Future
Modularized Content for Module 3
Author structured content blocks—such as manufacturing processes, specifications, and analytical methods—that can be reused across global submissions. Modular authoring supports consistent language, validated content, and localized flexibility.
Lifecycle Variation Management
When updates are required due to process changes, site transfers, or new data, Docuvera facilitates controlled updates with structured workflows to support variation management across markets.
Integrated Change Control and Impact Awareness
Updates to structured components trigger downstream impact notifications—ensuring no required document is missed, and changes are fully traceable and compliant.
Submission-Ready Output
Generate output formats aligned to Module 3 requirements, including eCTD-ready documents and XML—without reformatting or version copying. This supports faster turnaround and greater audit readiness.
Modular Authoring for Global Submissions
Create content blocks once and reuse them across geographies and filings.
Docuvera’s structured content platform allows CMC teams to author validated components for:
- Manufacturing processes
- Analytical methods
- Product specifications
- Equipment and facilities
These components are reused across global dossiers and updated centrally when regulations, sites, or processes change. Our platform supports the requirements of ICH M4Q for CTD Module 3 and enables rapid authoring of eCTD-ready content.
Post-Approval Change Management and Variation Control
Reduce risk and increase speed with automated impact tracking.
When a process changes, variation submissions often trigger global updates. Docuvera simplifies this with:
- Controlled workflows for lifecycle variation management
- Automated impact notifications across linked content
- Traceable change histories with full audit trails
Built-in support for ICH M12 and Q12 principles ensures that post-approval updates are consistent, efficient, and inspection-ready.
GenAI-Assisted Authoring and Review
Accelerate content creation while maintaining control.
Docuvera integrates GenAI capabilities to assist—not replace—human authors. Our AI models are trained on regulatory frameworks and can:
- Draft standard descriptions for processes and methods
- Suggest structured layouts based on ICH patterns
- Identify inconsistencies or missing data points
- Assist with metadata tagging and classification
All AI-generated suggestions are subject to human review, tracked for audit purposes, and configurable to meet GxP and validation standards.
Multilingual Content Management and Localization
Author once. Translate accurately. Reuse globally.
Global markets require consistent CMC documentation in multiple languages. Docuvera supports:
- Structured reuse of validated components across languages
- Seamless integration with Translation Management Systems (TMS)
- Market-specific content adaptation workflows
When changes are made to a core component, updates can be automatically reflected in all language versions—ensuring alignment and reducing retranslation cycles.
Centralized CMC Governance at Enterprise Scale
Centralize control, support GxP, and maintain continuous inspection readiness.
Docuvera is designed to support regulated content operations at scale, including:
- Validation-ready environments for 21 CFR Part 11 and Annex 11
- Role-based access and granular permissions
- Full content lifecycle traceability
- Component libraries aligned to regulatory document types
Your team gains a single source of truth for CMC documentation—eliminating duplicate content, rework, and manual tracking.
eCTD-Ready Output for Module 3
Produce submission-ready outputs with no reformatting.
Docuvera generates compliant outputs for CTD Module 3 in:
- eCTD-ready documents
- Structured XML formats
- Region-specific submission packages (EU, US, Japan)
This reduces formatting time, minimizes version errors, and supports rapid response to agency queries or variation submissions.
Business Value for CMC and Regulatory Operations
Structured content delivers measurable operational advantages:
| Challenge | Without Docuvera | With Docuvera |
| Manual tracking of CMC updates | Error-prone and siloed | Structured workflows and version-controlled content |
| Duplicate content across dossiers | High rework and reviewer fatigue | Reuse of approved content with modular variation |
| Submission formatting requirements | Time-consuming and redundant formatting | eCTD-ready structured outputs with minimal rework |
| Variation submissions across regions | Disconnected processes and risk of noncompliance | Centralized update propagation and full traceability |
Supported Regulatory Standards & Frameworks
Docuvera supports a wide range of pharmaceutical regulations and content standards, including:
- ICH M4Q – Quality documentation for CTD Module 3
- ICH M12 / Q12 – Post-approval lifecycle variation management
- 21 CFR Part 11 – Electronic records and signatures
- Annex 11 – EU GMP compliance for computerized systems
- eCTD 4.0 – Structured content delivery for regulatory submissions
- ISO IDMP – Identification of Medicinal Products
- HL7 FHIR – Interoperable data exchange