Gen AI and Agentic AI for Drug Safety and Pharmacovigilance
Drug safety and pharmacovigilance are critical components of public health, ensuring that medications are used safely and effectively. Pharmacovigilance involves monitoring the effects of drugs after they have been approved for use, aiming to identify and minimize adverse effects and other drug-related problems. Praxigent help companies to make sure they are FDA Compliant and meets the highest standard of FDA and ICH Regulations and utilize latest technology like Gen AI that play pivotal role in transforming predictive analysis on adverse event reporting by improving the speed and accuracy of signal detection, providing real-time risk predictions, and enhancing patient safety through advanced data processing, monitoring, and prediction capabilities.
"Harnessing Amazon Bedrock: PRAXIGENT's Custom Llama 3 70B LLM to Transform Pharmacovigilance"
Our Mission
Where deep pharmacovigilance expertise meets purposeful AI.
At Praxigent, our vision is a world where no patient safety signal goes undetected, no regulatory deadline is missed due to manual process failure, and no pharmacovigilance professional spends their expertise on work a machine should do. We believe the future of drug safety lies at the intersection of deep domain knowledge and purposeful AI — not generic automation, but intelligent agents that understand ICH guidelines, speak MedDRA, reason about benefit-risk, and act as tireless partners to the scientists and physicians who protect patients every day. PraxiVigilance is our commitment to that future: making safety organizations faster, sharper, and more resilient — so the industry can focus on what matters most.
Life Sciences Agentic AI Platform
PraxiVigilance by Praxigent — Intelligent Oversight for the Entire Drug Safety Lifecycle
PraxiVigilance is a multi-agent intelligence platform purpose-built for drug safety and pharmacovigilance professionals in pharma and biotech. Developed by Praxigent, it maps the complete PV lifecycle — from Drug Discovery through Preclinical, Clinical Trials, PV Intake, Safety Database management, Safety Analysis, Regulatory Reporting, and Signal Detection — deploying a dedicated AI agent at each stage. Each agent carries deep domain knowledge: the regulatory frameworks, data flows, system integrations, and failure points unique to its department. PraxiVigilance surfaces process redundancies, quantifies manual workload, and scores automation opportunities by effort and impact — so safety teams know exactly where to act and in what order. Unlike generic AI tools, PraxiVigilance speaks the language of the domain: MedDRA coding, ICH E2A/E2B/E2C compliance, Argus Safety workflows, disproportionality statistics, PSUR/PBRER authoring, and REMS/RMP management. Whether you are a VP of PV operations reducing ICSR submission risk, a medical officer streamlining aggregate analysis cycles, or a signal detection scientist moving beyond quarterly FAERS downloads — PraxiVigilance gives you a structured, data-driven command center to transform how your safety organization operates.PraxiVigilance agentic AI platform purpose-built for the regulated life sciences enterprise. Unlike point solutions that automate a single function, this platform deploys specialized AI agents across the full drug development and post-market lifecycle — Pharmacovigilance, Clinical Operations, Clinical Data Management, Regulatory Affairs, Quality, and Manufacturing — and orchestrates them through a shared platform of data connectors, regulatory knowledge, governance, and human-in-the-loop controls.
What We Offer
PRAXIGENT provides end-to-end pharmacovigilance and compliance solutions designed to adapt to your organization’s specific needs:
- Pharmacovigilance Strategy & Management: Comprehensive services that cover the entire pharmacovigilance lifecycle, from safety data management to signal detection and risk mitigation.
- Global Regulatory Compliance: Expert guidance on meeting FDA, ICH, and other regional regulatory standards.
- Safety Data Analysis & Reporting: Ensure timely and accurate safety reporting with our streamlined data analysis and submission services.
- Auditing & Inspections: Be audit-ready with our in-depth compliance audits and inspection readiness services.
- Risk Management & Mitigation Plans: We help you identify, evaluate, and mitigate risks effectively to maintain drug safety and compliance.
Top key FDA and ICH pharmacovigilance regulations Praxigent Specialized:
01
FDA Adverse Event Reporting Regulations (21 CFR Part 314.80
This regulation mandates that drug manufacturers report adverse events and product complaints for approved drugs, ensuring timely collection and analysis of safety data.
02
ICH E2E Pharmacovigilance Guideline
This guideline provides a comprehensive framework for the collection, management, and reporting of adverse drug reactions, promoting harmonization among regulatory authorities in the U.S., Europe, and Japan.
03
FDA REMS (Risk Evaluation and Mitigation Strategies)
Under the FDA's REMS program, certain drugs that pose significant risks require manufacturers to implement specific safety measures to ensure that the benefits outweigh the risks.
04
ICH E2B (Electronic Transmission of Individual Case Safety Reports)
This guideline outlines standards for the electronic submission of individual case safety reports (ICSRs), facilitating efficient data exchange between companies and regulatory authorities.
How Praxigent stand out...
- Regulatory Expertise: Our team is comprised of professionals with extensive knowledge of global pharmacovigilance regulations.
- Tailored Solutions: We provide customized services that cater to your unique business and product requirements.
- Innovative Tools: Our solutions incorporate the latest technologies to optimize efficiency and reduce compliance-related risks.
- Unmatched Support: PRAXIGENT delivers 24/7 support to ensure your business is always ready to meet the demands of regulatory authorities.
Partner with PRAXIGENT Today
Stay ahead of the curve in pharmacovigilance and compliance. With PRAXIGENT, you gain a reliable partner that will guide your organization through the intricacies of global regulatory frameworks, ensuring safety, accuracy, and success.