The Problem We Solve

Complex regulatory document creation is challenging.

Industry Challenge: Complex Regulatory Documents

Life sciences regulatory documents represent some of the most complex collaborative writing challenges in any industry, requiring coordination across multiple teams, organizations, and regulatory requirements.

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Scale
50+
Contributors across multiple departments and organizations
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Complexity
500+
Pages of highly technical, interconnected content
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Timeline
12+
Months of development with strict regulatory deadlines
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Organizations
5+
Different organizations with varying systems and processes

Manual Handoffs Between Systems

The lack of integration between existing products requires users to manually move documents from one system to another throughout the entire process, creating inefficiencies, errors, and version control nightmares.

  • Document creation in one system
  • Manual export and import for reviews
  • Separate approval workflows
  • Version conflicts during handoffs
  • Lost formatting and metadata
  • Time-consuming reconciliation processes
Fragmented Workflow Reality
Authoring Tool
Word/Docs
Review System
PDF/Email
Approval Tool
Separate App
Archive
File Server
⚠️ Manual handoffs at every step create bottlenecks, errors, and version conflicts
Version Control Chaos
Clinical_Summary_v3_FINAL.docx Conflict
Clinical_Summary_v3_FINAL_v2.docx Outdated
Clinical_Summary_REAL_FINAL.docx Conflict
Clinical_Summary_approved_final.docx Outdated

Limited AI Capabilities

Generative AI capabilities in current products are typically targeted at a single document type, therefore, multiple solutions are necessary to include all document types required for regulatory submission and approval.

  • AI tools limited to specific document types
  • No standardization across document categories
  • Inconsistent AI output quality
  • Lack incorporation of company standards
  • No integration with existing templates
  • Limited integration with existing templates

Unwieldy Document Access

Expert contributors must access and disturb the entire document to add, edit, or review content. This approach is unwieldy and difficult to control at the project level, leading to conflicts and coordination challenges.

  • Contributors see entire document unnecessarily
  • Simultaneous editing conflicts
  • Difficulty tracking individual contributions
  • Security concerns with full document access
  • Overwhelming complexity for focused tasks
  • Project managers lose control over access
847 Pages
Complex Regulatory Submission
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⚠️ Everyone needs access to everything = chaos and conflicts

Hyrding Provides a Comprehensive Solution

Hyrding has produced a fully integrated solution by leveraging the innovations of the Microsoft ecosystem for integration, control and AI applications in order to transform regulatory document creation. Together with cutting edge AI development expertise, Hyrding remains at the forefront of this highly evolving space.

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Complete Integration
End-to-end workflow within Microsoft ecosystem eliminates manual handoffs and version conflicts through seamless tool integration.
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All Document Types
Complete solution for clinical, pre-clinical, CMC, and labeling documents within a single platform
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Advanced AI Integration
Leveraging the newest wave of AI technology with specific user-directed agents that maintain control and consistency.
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Microsoft Teams Integration
Native integration with Microsoft Teams enables seamless collaboration and communication within familiar workflows.
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Elemental Control
Patent-pending technology provides granular document control while maintaining integrity and enabling focused collaboration.
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Life Sciences Expertise
Built by industry veterans with extensive life sciences experience who understand regulatory requirements intimately.