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Docuvera

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OVERVIEW

AI-powered structured content authoring (SCA) platform for regulated life sciences documentation, enabling content reuse and compliance.

Docuvera is an AI-powered Structured Content Authoring (SCA) platform developed specifically for the pharmaceutical and life sciences industries. It replaces traditional, scattered file-based workflows with modular, traceable, and compliant content components. The platform enables regulated content to be created once and reused across teams, document types, and global markets, which helps reduce cycle times, improve consistency, and modernize content operations.

Key benefits include accelerated compliance, increased efficiency (with claims of up to 50% lower operating costs), and faster time-to-market. The solution is built on a structured content framework and is designed to support the full content lifecycle, including Labeling (CCDS, SmPCs, USPIs), CMC (Module 3), Clinical (Protocols, CSRs), Medical Information, Pharmacovigilance & Safety, and Quality & SOPs.

It features collaborative review and approval workflows, robust version control, and a detailed audit trail to ensure GxP and regulatory compliance. Docuvera is a validation-ready SaaS solution hosted on SOC 2-certified infrastructure and is engineered to align with evolving regulatory and interoperability standards like eCTD 4.0, ePI, DADI, and HL7 FHIR. It is designed to complement existing RIM, QMS, and publishing systems through seamless integrations.

RATING & STATS

Customers
100+
Founded
2017

KEY FEATURES

  • AI-Powered Structured Content Authoring (SCA)
  • Component-Based Content Reuse
  • Collaborative Review and Approval Workflows
  • GxP-Compliant Audit Trail and Version Control
  • Multichannel Publishing (eCTD, ePI, PDF, XML)
  • Global-to-Local Variation Management
  • Impact Analysis and Change Propagation

PRICING

Model: enterprise
Pricing is not publicly disclosed and is based on an enterprise subscription model, likely involving user seats, modules, and implementation services.

TECHNICAL DETAILS

Deployment: saas, cloud
Platforms: web
🔌 API Available

USE CASES

Global Labeling (CCDS, SmPC, USPI)CMC (Chemistry, Manufacturing & Controls) DocumentationClinical Documentation (Protocols, CSRs, IBs)Medical Information Response CreationPharmacovigilance & Safety WritingQuality & SOPs Management

INTEGRATIONS

Veeva VaultMicrosoft SharePointEXTEDOpulseRIM SystemsQMS Systems

COMPLIANCE & SECURITY

Compliance:
SOC2GxPICH E3ICH M11eCTD 4.0ePIHL7 FHIR
Security Features:
  • 🔒Audit Trail
  • 🔒Role-Based Access Control
  • 🔒SOC 2-Certified Infrastructure
  • 🔒Encryption

SUPPORT & IMPLEMENTATION

Support: email, phone, dedicated account manager, knowledge base
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Significantly reduces content creation and review cycle times
  • +Ensures content consistency and compliance across global markets
  • +Purpose-built for regulated life sciences content (e.g., eCTD 4.0, ePI)
  • +Component-based reuse maximizes efficiency and accuracy
  • +Integrates with existing RIM/QMS systems (e.g., Veeva Vault)
✗ Cons:
  • -Pricing is not publicly available (enterprise model)
  • -Requires significant change management for adoption in large organizations
  • -No public third-party reviews or ratings available

ABOUT DOCUVERA