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Regulated Safety Documentation, Powered by NavaX AI

Embed AI across the PV document lifecycle to strengthen compliance, accelerate submissions, and produce higher-quality regulatory documents at scale.

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Regulated Safety Documentation, Powered by NavaX AI

Embed AI across the PV document lifecycle to strengthen compliance, accelerate submissions, and produce higher-quality regulatory documents at scale.

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LifeSphere® Technology is trusted by these industry leaders:

Advanced Compliance Docs

Advanced Compliance Docs, powered by NavaX AI, embeds AI-powered capabilities across the creation, management, and maintenance of regulated Safety documentation such as PBRER, DSUR, PADER, as well as Pharmacovigilance Agreements (PVAs) and Pharmacovigilance System Master Files (PSMFs). The solution replaces fragmented and manual processes with intelligent automation that orchestrates document authoring, review, approval, and submission.

Efficiency Gains

Drive faster submissions by automating and augmenting critical workflows, including reducing manual document authoring by up to 70-80%.

Cost Savings

Automate manual processes, including medical writing authoring and management, to reduce labor and error-related expenses.

Audit and Inspection Readiness

Strengthen global compliance with enhanced traceability and inspection readiness via centralized document management and intelligent workflows.

Quality and Consistency

Produce higher-quality regulatory documents through AI-assisted content generation that ensure more consistent, reliable outcomes at scale.

Features

Deliver real value with Advanced Compliance Docs.

AI-Assisted Report Authoring

Harness AI to automatically gather, synthesize, and contextualize information from multiple sources and pre-populate report templates.

Intelligent Report Reuse

Enable faster, more consistent report creation by intelligently updating sections with the latest information from previously authored reports.

Collaborative Review

Support secure multi-author collaboration with configurable review workflows, version control, electronic approvals, and complete audit trails.

Pharmacovigilance Agreement (PVA) Management

Simplify the creation, review, approval, and maintenance of PVAs using standardized templates and intelligent workflow automation.

Pharmacovigilance System Master File (PSMF) Management

Maintain inspection-ready PSMFs through centralized content management, automated change tracking, and lifecycle controls.

Operational Dashboards

Gain real-time visibility into document status, reporting timelines, submission readiness, and operational performance.

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the latest automation from LifeSphere

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Discover NavaX

the latest automation from LifeSphere

Learn More

Resources

Get in touch to see the value you can achieve with LifeSphere.

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Advanced Compliance DocsMladen Prenc2026-07-30T14:50:42+00:00

ArisGlobal is a pivotal partner in the life sciences industry, specializing in solutions that drive drug development, safety monitoring, and regulatory compliance. We collaborate with more than 220 global life sciences companies, CROs, and government health authorities, including leading biopharmaceutical firms and regulatory bodies such as FDA, Health Canada, and NMPA.
Headquartered in the United States, ArisGlobal has regional offices in Europe, India, Japan and China.

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Regulated Safety Documentation, Powered by NavaX AI

Embed AI across the PV document lifecycle to strengthen compliance, accelerate submissions, and produce higher-quality regulatory documents at scale.

Let's Talk

Get started!

Regulated Safety Documentation, Powered by NavaX AI

Embed AI across the PV document lifecycle to strengthen compliance, accelerate submissions, and produce higher-quality regulatory documents at scale.

LifeSphere® Technology is trusted by these industry leaders:

Advanced Compliance Docs

Features

Deliver real value with Advanced Compliance Docs.

Resources

Get in touch to see the value you can achieve with LifeSphere.

Get started!

Experience LifeSphere in Action. Contact Us!