Medifodil- Smart Pharma Solutions

Adverse Event Detection & Case Processing

End-to-end adverse event case management, from intake to regulatory submission.Case triaging, seriousness assessment, and medical review.Compliance with FDA (FAERS), EMA (EudraVigilance), WHO UMC, and India’s PvPI requirements.

Signal Detection & Risk Analysis

AI-based safety signal identification and validation. Risk-benefit analysis to assess potential regulatory actions. Preparation of Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and Pharmacovigilance System Master Files (PSMFs).

Medical Literature Surveillance

Continuous monitoring of scientific journals, case studies, and clinical research publications. Literature screening for adverse event reports and safety concerns. Timely reporting to global regulatory authorities.

Global Regulatory Safety Submissions

Preparation and submission of Individual Case Safety Reports (ICSRs). Development Safety Update Reports (DSURs) for clinical trials. Compliance with ICH E2E pharmacovigilance reporting guidelines.

Automation & AI-Enabled Pharmacovigilance

Implementation of robotic process automation (RPA) for case processing. Use of natural language processing (NLP) to extract safety information from unstructured data. AI-powered predictive analytics for risk mitigation.

Let’s Build a Smarter Pharma Future Together

safer Compliance Excellence Integrity Transparency Client-Centric Approach Pharmacovigilance clinical research regulatory Marketing Quality innovation Consulting