Accelerate technical documentation and regulatory submissions by 75%

Our AI platform automates document authoring, reviews, and submissions throughout your operations from early R&D through initial dossier filings to ongoing lifecycle management.

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Benefits

Outcomes That Redefine Regulatory Efficiency

10× Faster Documentation Cycles

Accelerate end-to-end documentation cycles by reducing rework, streamlining reviews, and keeping content aligned.

10× Faster Documentation Cycles

Accelerate end-to-end documentation cycles by reducing rework, streamlining reviews, and keeping content aligned.

10× Faster Documentation Cycles

Accelerate end-to-end documentation cycles by reducing rework, streamlining reviews, and keeping content aligned.

First Drafts in Minutes, Not Weeks

Generate complete, structured first drafts in minutes, eliminating weeks of manual authoring and setup.

First Drafts in Minutes, Not Weeks

Generate complete, structured first drafts in minutes, eliminating weeks of manual authoring and setup.

First Drafts in Minutes, Not Weeks

Generate complete, structured first drafts in minutes, eliminating weeks of manual authoring and setup.

99.9% Reduction in Errors

Significantly reduce errors through consistent structure, traceability, and built-in quality checks across documentation.

99.9% Reduction in Errors

Significantly reduce errors through consistent structure, traceability, and built-in quality checks across documentation.

99.9% Reduction in Errors

Significantly reduce errors through consistent structure, traceability, and built-in quality checks across documentation.

Platform Capabilities

Capabilities That Bring Structure to Regulatory Work

One-Click Document Drafting

Produce first drafts of scientific and regulatory documents within mintues — aligned to your templates, SOPs and global guidelines, with built-in verification and traceability.

One-Click Document Drafting

Produce first drafts of scientific and regulatory documents within mintues — aligned to your templates, SOPs and global guidelines, with built-in verification and traceability.

AI-Assisted Review

Use AI as an additional reviewer to spot gaps, inconsistencies, and quality issues—supporting thorough reviews and right-first-time submissions without replacing human judgment.

AI-Assisted Review

Use AI as an additional reviewer to spot gaps, inconsistencies, and quality issues—supporting thorough reviews and right-first-time submissions without replacing human judgment.

End-to-End Traceability

Maintain clear traceability across source data, document sections, and revisions so reviewers can quickly understand what changed, why, and where—accelerating review cycles.

End-to-End Traceability

Maintain clear traceability across source data, document sections, and revisions so reviewers can quickly understand what changed, why, and where—accelerating review cycles.

Configured to Your Processes

Align the platform to your existing data, templates, and regulatory processes, letting teams work within familiar structures while maintaining consistency—without forcing new ways of working.

Configured to Your Processes

Align the platform to your existing data, templates, and regulatory processes, letting teams work within familiar structures while maintaining consistency—without forcing new ways of working.

Easy Formatting

Create tables, lists, figures, and apply document styles with ease using our built-in “Refine with AI”. Eliminate the lengthy manual work and last-minute rework!

Easy Formatting

Create tables, lists, figures, and apply document styles with ease using our built-in “Refine with AI”. Eliminate the lengthy manual work and last-minute rework!

Built-In Collaboration

Collaborate in real time with shared access, comments, and version control. Keep teams aligned across drafting, review, and preparation stages without version confusion or email-based reviews.

Built-In Collaboration

Collaborate in real time with shared access, comments, and version control. Keep teams aligned across drafting, review, and preparation stages without version confusion or email-based reviews.

Enterprise Control & Security

Designed for Enterprise Trust and Control

Zero Data Storage and Zero Training Agreement with LLM Providers

Your regulatory data is not stored or used to train external LLM providers. All processing is designed to ensure sensitive content remains under your control, supporting strict confidentiality and data-privacy requirements.

Zero Data Storage and Zero Training Agreement with LLM Providers

Enterprise-Grade Security

Built to align with recognized enterprise security and privacy standards, including ISO, SOC 2, HIPAA, and GDPR—supporting deployment in regulated and high-trust environments.

Enterprise-Grade Security

Built to align with recognized enterprise security and privacy standards, including ISO, SOC 2, HIPAA, and GDPR—supporting deployment in regulated and high-trust environments.

Enterprise-Grade Security

Built to align with recognized enterprise security and privacy standards, including ISO, SOC 2, HIPAA, and GDPR—supporting deployment in regulated and high-trust environments.

IP Whitelisting and Network Access Control

Deploy the platform with IP address whitelisting to restrict access at the network level. This ensures only approved enterprise networks can access the system, adding an extra layer of security.

IP Whitelisting and Network Access Control

Deploy the platform with IP address whitelisting to restrict access at the network level. This ensures only approved enterprise networks can access the system, adding an extra layer of security.

IP Whitelisting and Network Access Control

Deploy the platform with IP address whitelisting to restrict access at the network level. This ensures only approved enterprise networks can access the system, adding an extra layer of security.

Industries we support