Trusted by the world’s best

Backed by Leading Technology and Innovation Partners

  • Microsoft logo

    Global Strategic Partner for AI Document Authoring

  • Google logo

    Ex-Google engineers, backed by Google for Startups.

  • Veeva AI Partner logo

    Integrates with Veeva and enterprise ecosystems.

  • NVIDIA Inception Program logo

    NVIDIA Inception member, powering enterprise GenAI.

  • Johnson & Johnson Innovation - JLABS logo

    Innovation collaborator through J&J JLABS.

Engineered for Pharmaceutical Teams

Medical Writers and Regulatory Professionals

Spend less time on routine drafting and more on scientific quality — with AI that handles synchronization, formatting, and consistency checks automatically.

Regulatory Affairs and R&D Leaders

Accelerate IND, NDA, BLA, and MAA submissions with end-to-end pharma R&D document automation across the full drug development lifecycle.

IT and Digital Innovation Teams

Deploy a GxP-compliant AI writing platform for life sciences with native Microsoft 365 integration, Veeva API connectivity, and 21 CFR Part 11-compliant audit trails.

Automate Regulatory Authoring Across the Full Drug Development Lifecycle

Streamline the Submission Lifecycle

  • End-to-End R&D Document Automation
  • Comprehensive eCTD Coverage
  • Faster IND, NDA, BLA & MAA Filings

AI-Powered Regulatory Authoring

  • Drafts Grounded in Your Own Verified Regulatory Documents
  • Cross-eCTD Document Network and Linkage Across Modules 1 to 5
  • Content Change Orchestration Across Linked Documents and Markets
  • End-to-end QC and Review
  • Continuous Audit Readiness with 21 CFR Part 11-Compliant Audit Trails
 Automate Regulatory Authoring Across the Full Drug Development Lifecycle

Accelerate Authoring Across All Core Regulatory Dossiers

An out-of-the-box solution supporting comprehensive clinical, nonclinical, and CMC authoring to accelerate your path to submission.

Clinical

  • Protocol & Amendments
  • M5 Clinical Study Reports (CSR)
  • M2.7.3 Summary of Clinical Efficacy
  • M2.7.4 Summary of Clinical Safety
  • M2.5 Clinical Overview

CMC

  • M3 Quality Documentation
  • M2.3 Quality Overall Summary (QOS)

Nonclinical

  • M2.4 Nonclinical Overview
  • M2.6 Nonclinical Written & Tabulated Summaries
  • M4 Nonclinical Study Reports

Trusted by Pharma Companies and CROs Globally

AuroraPrime is the AI writing solution for pharmaceutical companies trusted by leading global pharma and CROs. 

21 CFR Part 11-Compliant | ISO 9001 and ISO 27001 Certified | 92 to 317% Proven ROI

Customer Success

If we can accelerate our submission one day, that is an additional earning. The exchange from simulated to real data will completely transform the way pharma companies work with submissions — and we can only do that because we have your tool available.
Head of Regulatory Medical Writing, Leading Global Pharma

New White Paper Avaliable

New White Paper Avaliable

Download the Frost & Sullivan Report: How Leading Pharma & CROs Are Scaling AI with Built-In Quality Control

Produced in collaboration with AlphaLife Sciences, this white paper from Frost & Sullivan captures exclusive insights from global industry leaders — including Heads of Biometrics and Medical Writing at top pharma companies and CROs, alongside experts from Microsoft and former FDA officials.

Download Report

AuroraPrime RMA

A Microsoft Word 365 add-in and AI platform for medical content authoring across the complete R&D document lifecycle, built for 21 CFR Part 11-compliant pharmaceutical workflows. 

  • Cross-Functional R&D Document Support Spanning Clinical, Nonclinical, CMC, Safety, and Post-Market
  • Configurable eCTD Templates with Content Reuse Across Modules and Markets
  • IND, NDA, BLA, and MAA Filing Acceleration from Initial Drafting to Final Review and Submission
Book a Demo Learn More

Products & Services

AuroraPrime RMA

AI-Powered Regulatory Authoring

Accelerate R&D documentation with a scalable, compliant AI platform. RMA grounds drafting in your verified regulatory content, integrates natively with Microsoft Word and Veeva Vault, and keeps medical writers in control from first draft to final approval.

Explore AuroraPrime RMA

AuroraPrime DocMind

Enterprise AI Engine for Pharma

Empower pharma IT to build, scale, and orchestrate enterprise AI content and data solutions. A composable architecture lets internal teams manage templates, workflows, and integrations independently — purpose-built for regulated life sciences, not retrofitted from generic AI.

Explore DocMind

AuroraPrime Expert

AI-Accelerated Authoring Services

Deliver submission-ready documents faster and to enterprise-grade standards. AlphaLife Sciences pairs AuroraPrime automation with senior medical writing and regulatory expertise — applying the same human-in-the-loop principle to your most time-critical documents.

Explore Expert Services

Built for Enterprise Trust and Compliance

AuroraPrime is built for the compliance, security, and validation standards that regulated pharma R&D demands. Our pharma R&D document automation solution operates within 21 CFR Part 11, HIPAA, GDPR, SOC 2 Type II, ISO 9001, and ISO 27001 frameworks, with adherence to global standards.

  • Clinical Data Interchange Standards Consortium
  • FDA 21 CFR Part 11 logo
  • HIPAA Compliant logo
  • GDPR logo
  • SOC 2 Type I logo
  • ISO 9001 logo
  • ISO 27001 logo

Latest News

AlphaLife Sciences and Veeva Finalize Strategic Product Partnership

AlphaLife Sciences finalizes its strategic product partnership with Veeva, enabling seamless Veeva Vault RIM integration for AI-orchestrated regulatory authoring.
May 06, 2026

AlphaLife Sciences Announces Veeva RIM Integration to Power AI-Orchestrated Authoring and QC

AlphaLife Sciences Announces Veeva RIM Integration to Power AI-Orchestrated Authoring and QC
Mar 30, 2026

Microsoft x AlphaLife: Powering Regulatory-Compliant AI Workflows with PostgreSQL on Azure

🚀 What happens when enterprise-grade cloud infrastructure meets domain-specific AI for life sciences?In our latest collaboration with Microsoft, we demonstrate how PostgreSQL on Azure can power secure, high-performance AI pipelines designed specifically for the stringent requirements of the life sciences industry. The result: faster insights, stronger compliance, and AI workflows that are ready for real-world regulatory environments.From structured regulatory data to intelligent document workflows, this partnership shows how modern cloud databases and AI-driven platforms can work together to unlock a new era of operational efficiency and scientific productivity.If you're exploring how AI and cloud infrastructure can reshape regulatory operations, this is a story worth reading.
Mar 10, 2026

Frequently Asked Questions About AlphaLife Sciences

How is AlphaLife Sciences different from other AI vendors in life sciences? AlphaLife Sciences is purpose-built for regulated pharma R&D, not retrofitted from generic enterprise AI. AuroraPrime grounds every output in your verified source documents through RAG architecture, keeps medical writers in control with human-in-the-loop AI, and is trusted by more than half of the top global pharmaceutical companies.
AuroraPrime automates regulatory and medical authoring across pre-clinical, clinical, CMC, safety, labeling, and post-market workflows. From Protocols and CSRs to DSURs, PSURs, CMC documentation, and Package Inserts, one AI platform for medical content authoring supports every document type from IND through NDA, BLA, and MAA submission.
AlphaLife Sciences operates within 21 CFR Part 11, HIPAA, GDPR, SOC 2 Type II, ISO 9001, and ISO 27001 frameworks, with adherence to global standards including GCP. Every authored document includes 21 CFR Part 11-compliant audit trails, source traceability, and version control for inspection-ready regulatory submissions.

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