Viginovix, a technology focused pharmacovigilance company, announced the official launch of PVAxchange, a centralized, GxP-validated SaaS platform purpose-built to streamline the creation, negotiation, management and governance of Safety Data Exchange Agreements (SDEAs) across their entire lifecycle. PVAxchange is now live and available to pharmaceutical companies, biotech firms, CROs and marketing authorization holders worldwide.
Managing SDEAs — the formal contracts that govern the exchange of pharmacovigilance data between partners — has long been a resource-intensive, error-prone process handled through a patchwork of spreadsheets, email chains and generic contract management tools. PVAxchange replaces this fragmented approach with a single, inspection-ready platform engineered specifically for pharmacovigilance workflows.
Solving a Critical Industry Gap
Safety Data Exchange Agreements are a regulatory cornerstone of pharmacovigilance operations. Failure to maintain them effectively missing review deadlines, losing version history, or being unable to demonstrate compliance during a health authority inspection can expose companies to significant regulatory risk. PVAxchange was designed from the ground up by PV practitioners to eliminate these risks.
"The SDEA management challenge is one of the most underserved pain points in pharmacovigilance operations. Pharmaceutical companies manage dozens, sometimes hundreds, of partner agreements — and yet there has been no dedicated platform to manage them. PVAxchange changes that entirely," said Dr. Upendra Nagaich, CEO of Viginovix and SPER Market Research.
How PVAxchange Helps Pharmaceutical Companies
PVAxchange delivers six core capabilities that directly address the operational and compliance challenges pharmaceutical companies face in managing their SDEA portfolios:
1. Faster SDEA Creation with Smart Templates
Dynamic, auto-generated SDEA templates enable legal and PV teams to initiate new agreements in minutes rather than days, ensuring consistency across the partner network and eliminating the blank-page problem for every new licensing deal, co-marketing arrangement or clinical collaboration.
2. End-to-End Lifecycle Governance
From initial drafting through QC review, stakeholder negotiation, approval and archival, PVAxchange manages the complete SDEA lifecycle in one place. Automated review triggers and configurable periodic review cycles with smart reminders ensure no agreement lapses unnoticed.
3. In-Platform Negotiation — No More Email Redlines
PVAxchange enables internal teams and external partners to collaborate on agreement redlines directly within the platform, eliminating version confusion, lost email threads and the compliance gaps that arise from out-of-system negotiations.
4. 21 CFR Part 11 Audit Trail for Inspection Readiness
Every action on the platform drafts, edits, approvals, sign-offs is captured in a tamper-evident, time-stamped audit log with electronic signatures fully compliant with 21 CFR Part 11. Companies can meet health authority inspections with complete, instant traceability across the entire SDEA portfolio.
5. Intelligent Deliverables Exchange
Structured exchange of safety deliverables — including periodic safety update reports (PSURs), safety signals and ICSR notifications is managed within PVAxchange with tracked acknowledgements, reducing the risk of missed obligations that sit at the heart of many regulatory findings.
6. Real-Time Compliance Dashboards
Interactive dashboards provide heads of pharmacovigilance and compliance officers with instant visibility into SDEA portfolio health, partner performance, upcoming renewal deadlines and obligation status — enabling proactive governance rather than reactive fire-fighting.
Built by PV Experts, Not Repurposed Technology
Unlike generic contract lifecycle management (CLM) tools adapted for pharma use, PVAxchange was architected by pharmacovigilance practitioners with deep expertise in PVA/SDEA Management. The platform's workflows mirror real-world PV operations, not generic procurement or legal processes.
PVAxchange is validated under GxP requirements and operates on a cloud-based SaaS model, enabling pharmaceutical companies to go live in weeks with no infrastructure investment and predictable subscription-based pricing — significantly reducing total cost of ownership compared to on-premise or custom-built solutions.
"We built PVAxchange because we spent years managing SDEAs for our clients and saw first-hand how broken the status quo was. PVAxchange is the platform we always wished existed," said Awanish Kumar Pandey, Head of Business Strategy & PV Operations at Viginovix.
Part of a Broader PV Technology Platform
PVAxchange is one of several live tools within Viginovix's growing pharmacovigilance technology portfolio, which also includes:
• VGRID — Regulatory Intelligence Database with Aggregate Report Scheduler
• Advanced Literature Tool — AI-powered smart screening and deduplication
• Signal Tool — Real-time pharmacovigilance signal detection
• Co-Authoring Solutions

All platform tools are backed by Viginovix's full-service pharmacovigilance and regulatory affairs practice, spanning case management, scientific writing, risk and signal management, Europe/UK regulatory services and PV consulting, making Viginovix a single accountable partner across both technology and operations.
Availability
PVAxchange is available immediately for pharmaceutical companies, biotech firms, CROs and MAHs globally. Interested organizations are invited to request a demonstration through the Viginovix website or by contacting the business development team directly.

About Viginovix
Viginovix is the pharmacovigilance and regulatory services division of SPER Market Research, delivering end-to-end solutions in drug safety, regulatory affairs and PV technology to pharmaceutical companies worldwide. With offices in Noida, Hyderabad and London, Viginovix combines deep domain expertise with purpose-built technology to safeguard patient well-being globally. Learn more at viginovix.com.

Media & Business Enquiries
Awanish Kumar Pandey | Head, PV Strategy & Operation
Email: [email protected]
Web: viginovix.com