Hyderabad, Telangana-500072 +91 9032115695 info@Medifodil.com

QMS & Technology-Driven Pharma Solutions

Home QMS & Technology-Driven Pharma Solutions

AI-Powered Pharmacovigilance Analytics

Predictive safety signal detection using AI-driven analytics. Automated case processing and adverse event classification. Machine learning-based identification of drug safety trends. Real-time data mining for global pharmacovigilance surveillance.

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Regulatory Compliance Automation

AI-driven regulatory monitoring to track global compliance updates. Automated generation of regulatory submissions (CTD/eCTD, PSURs, DSURs, RMPs). Real-time validation of compliance gaps and recommendations for corrective actions. Intelligent automation for audit trail management and reporting.

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Blockchain-Enabled Data Integrity

Tamper-proof blockchain solutions for pharmaceutical data security. Ensuring end-to-end data traceability in clinical trials and supply chains. Smart contracts for automated regulatory submissions and compliance enforcement. Preventing data falsification and enhancing transparency in drug development.

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Digital Twin Technology for Pharma

AI-powered digital replicas of manufacturing and research processes for predictive analysis. Virtual simulation of drug production to optimize efficiency and quality. Real-time monitoring of clinical trials, drug development, and regulatory workflows. Early detection of manufacturing deviations and process failures before they impact production.

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Let’s Build a Smarter Pharma Future Together

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Medifodil Smart Pharma Solutions

At Medifodil Smart Pharma Solutions, we specialize in Quality Management Systems (QMS) and cutting-edge technology solutions tailored for the pharmaceutical, biotechnology, and healthcare industries. Our focus is on integrating AI, automation, and advanced analytics to enhance compliance, improve operational efficiency, and ensure data integrity.A robust QMS is essential for maintaining regulatory compliance, ensuring product quality, and minimizing operational risks. We provide end-to-end QMS solutions, integrating AI-driven insights and best practices to help pharmaceutical companies achieve Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP) compliance.

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Quality Management Systems (QMS)

AI-Optimized QMS Implementation

AI-driven risk assessment to identify potential quality gaps. Automated compliance tracking and deviation management. Intelligent workflow automation for document control, audits, and CAPA. Real-time QMS dashboard for continuous monitoring and predictive analytics.

GMP, GCP, and GDP Compliance

End-to-end support for GMP (Manufacturing), GCP (Clinical), and GDP (Distribution) compliance. Assistance with regulatory inspections and adherence to FDA, EMA, WHO, CDSCO, and MHRA guidelines. AI-driven compliance scorecards to measure and improve regulatory readiness. Real-time monitoring of production, storage, and distribution processes to maintain pharmaceutical quality standards.

Risk-Based Quality Audits & CAPA Strategies

AI-enabled risk-based audit planning to focus on high-impact compliance areas. Mock audits and regulatory inspection readiness programs. Development and implementation of Corrective and Preventive Action (CAPA) plans. Root Cause Analysis (RCA) using machine learning for proactive risk mitigation.

SOP & Document Control Systems

Cloud-based Standard Operating Procedures (SOPs) and Document Control Systems for real-time access. AI-enabled version control and compliance tracking for SOP updates. Automated alerts and workflows to ensure timely SOP revisions and approvals. Integration with regulatory submission platforms for seamless documentation.

Medifodil

We help pharmaceutical companies stay ahead in a dynamic regulatory landscape by blending science, strategy, and technology.

Get In Touch

MIG-577, Satya ENCLAVE, 3rd floor, near NSL centrum, road number-1, kphb, phase-1, Hyderabad, Telangana-500072

info@Medifodil.com

+91 9032115695

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