ArisGlobal AI suite (XDI/NavaX) streamlines pharmacovigilance and submissions, aids Wave Life Sciences

AI-driven overhaul targets pharma safety and submissions

ArisGlobal unveils integrated XDI and NavaX suite for PV and regulatory teams

ArisGlobal is launching a suite of AI tools designed to standardize and accelerate pharmacovigilance and regulatory workflows across drug development, a development that matters to biotech companies such as Wave Life Sciences and others working on oligonucleotide and advanced therapies. The company introduces XDI, a system-agnostic data intelligence cortex, together with three new NavaX AI agents and NavaX Translation, which together aim to unify meaning, context and intent across Safety, Regulatory, Clinical, Quality and Manufacturing functions. ArisGlobal positions the stack as explainable AI that reduces interpretive drift and produces audit‑ready evidence alignment across enterprise R&D systems.

XDI acts as a cross‑functional layer that accesses disparate data sources to support consistent, explainable decisions and governed traceability, enabling safety and regulatory teams to operate from the same evidence base. The expanded NavaX Agents Suite adds Intelligence Agents to automatically interpret evolving regulatory guidance, convert it into rule checklists and score submission compliance; Distribution Agents to continuously validate distribution logic against new guidance and trigger managed change workflows; and Signals Agents to interpret user intent, plan analytical approaches and orchestrate cross‑functional reasoning. Together, these capabilities aim to cut manual review, shorten cycle times for submissions and safety case processing, and provide traceability and confidence scores that support enterprise adoption.

For companies like Wave Life Sciences, which face stringent global safety reporting and complex regulatory submissions for novel modalities, the platform promises faster decision‑making and reduced operational risk. ArisGlobal frames the offering as enabling sponsors, CROs and pharmacovigilance teams to operationalize governed AI at scale, with measurable time‑to‑value and improved submission quality while preserving audit readiness and compliance.

Translation partnership slashes intake time

ArisGlobal also unveils NavaX Translation, developed with TransPerfect Life Sciences, which embeds certified translation into PV case intake. Non‑English safety forms route to pharma‑specific language models and expert linguists and return via API into LifeSphere, cutting translation handling from roughly five hours per case to under a minute and removing a major manual bottleneck in global safety operations.

Implications for sponsors and CROs

The integrated platform is presented as a tool for sponsors and CROs to maintain continuous compliance and governed traceability across global operations, potentially reshaping how biotech firms manage safety, regulatory submissions and cross‑functional evidence alignment.