CMC Documentation in Pharma: Structured, Scalable, Compliant
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 validated data lineage, traceability, and interoperability.
CMC content doesn’t start at the document—it starts at the data source. Docuvera ingests information from upstream systems such as:
Source data is transformed into governed, component-based content aligned to established quality frameworks and the CMC expectations defined in ICH M4Q and the emerging M4Q(R2) update. All components are version-controlled, traceable, and fully auditable.
With support for standards-based APIs and FHIR where applicable to regulatory data exchange, Docuvera ensures consistent, interoperable content flows between manufacturing and regulatory systems.
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:
These components are reused across global dossiers and updated centrally when regulations, sites, or processes change. Our platform supports the requirements of ICH M4Q/M4QR2 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:
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:
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.
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:
Your team gains a single source of truth for CMC documentation—eliminating duplicate content, rework, and manual tracking.
eCTD-Ready Output for Module 3
Docuvera generates compliant outputs for CTD Module 3 in:
This reduces formatting time, minimizes version errors, and supports rapid response to agency queries or variation submissions.