The Pravartan team helps life sciences companies integrate AI solutions, ensuring compliance with the FDA's risk-based credibility assessment framework. Our approach includes:

• AI Strategy Development: We work with your IT and business teams to define AI use cases that align with regulatory requirements and support your business priorities and strategic initiatives, driving better business outcomes.
• Risk-Based Model Assessment: We help evaluate AI models based on their intended use, model influence, and potential compliance risks. We guide in how you can apply a risk-based approach to the development, validation, and ongoing use of your AI solution.
• AI Validation and Governance: Our technology experts implement rigorous validation processes to ensure AI outputs are reliable, explainable, and auditable.
• Regulatory Documentation Support: We assist in preparing documentation demonstrating AI models' credibility according to the FDA's expectations.
• Continuous Monitoring and Compliance Management: Our solutions include built-in compliance controls and ongoing monitoring to manage AI performance over time.

We help companies benefit from AI while mitigating regulatory risks and ensuring patient safety and drug/device quality.

• Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products
• Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

Generative AI can transform life sciences by accelerating drug discovery, optimizing clinical trial designs, and enhancing regulatory compliance. Our solutions help:

• Automate content creation for regulatory submissions.
• Develop internal chatbots for efficient proprietary knowledge management.
• Streamline workflows with AI agents to improve operational efficiency.
• Support compliance validation through intelligent data analysis.

We leverage a range of advanced technologies to build robust AI solutions, including:

• Generative AI for content creation and process automation.
• AI agents to streamline workflows and decision-making.
• Machine Learning frameworks for predictive analytics.
• Natural Language Processing (NLP) to interpret and manage complex datasets.
• Computer Vision for image and pattern recognition.

These technologies seamlessly integrate with cloud platforms and data tools to deliver comprehensive, scalable solutions.

Our AI solutions empower life sciences organizations to:

• Enhance compliance risk management to meet regulatory standards.
• Increase clinical trial efficiency through predictive modeling and optimized trial design.
• Automate supply chain operations for better resource management and reduced delays.
• Utilize predictive maintenance to ensure the reliability of critical equipment.
• Improve patient outcomes by identifying therapeutic opportunities faster and with greater accuracy.

Pravartan partners with a wide range of life sciences organizations, including:

• Pharmaceutical companies
• Biotechnology firms
• Medical device manufacturers
• Clinical Research Organizations (CROs)
• Contract Development and Manufacturing Organizations (CDMOs)

We offer tailored AI solutions to meet the unique needs of each sector, helping organizations innovate while ensuring compliance and operational efficiency.