Hyderabad, 1 April 2025— Entvin AI, a startup founded by three IIT Bombay graduates, has secured Rs. 5 crore ($500,000) in funding from the globally renowned startup accelerator Y Combinator. With an acceptance rate of just 0.1%, this funding marks a significant milestone for the AI-driven regulatory compliance startup, which aims to streamline the complex and time-consuming FDA drug approval process for pharmaceutical companies.
Founded by Sanskar Jain, Hemant Phalak, and Rishabh Arya, Entvin AI has developed an advanced artificial intelligence platform designed to assist pharmaceutical and life sciences companies in navigating the stringent and often lengthy regulatory landscape. The startup, which has recently emerged from its beta phase, has already demonstrated early success in its pilot programs with enterprise clients. Its AI-driven system is designed to save hundreds of hours for regulatory and scientific teams while ensuring greater compliance accuracy, a key aspect in an industry where minor regulatory errors can result in financial losses worth millions.
Addressing a Multi-Billion Dollar Market Opportunity
The pharmaceutical industry is highly regulated, with the FDA approval process alone taking several years and incurring substantial costs. The compliance and documentation processes involved are resource-intensive, requiring pharmaceutical companies to dedicate extensive manpower to regulatory submissions, compliance verification, and ongoing monitoring.
Entvin AI has positioned itself as a game-changer in this domain by automating key compliance tasks that traditionally consume thousands of hours of highly skilled professionals’ time. The startup’s AI-powered platform leverages large language models (LLMs) that have been specifically fine-tuned for regulatory documentation, FDA compliance standards, and industry best practices.
By implementing AI-driven automation, pharmaceutical companies using Entvin’s solution can significantly cut down the time spent on compliance-related work while improving overall accuracy. The market for regulatory technology in the pharmaceutical industry is vast, with companies globally seeking solutions that can help expedite approval timelines and optimize costs. With its funding from Y Combinator, Entvin AI aims to scale its platform, enhance AI capabilities, and accelerate customer acquisition among mid-to-large pharmaceutical enterprises worldwide.
How Entvin’s AI Platform Works
Entvin AI’s technology is built to directly address the bottlenecks that pharmaceutical companies face in regulatory compliance. The platform is designed to automate several critical functions, including:
- Document Drafting: Automatically generating regulatory submissions and compliance reports, reducing the burden on regulatory professionals.
- Compliance Verification: Identifying inconsistencies and gaps in regulatory documentation to ensure accuracy before submission.
- Regulatory Monitoring: Keeping track of evolving FDA guidelines and automatically updating relevant documentation to maintain compliance.
- By integrating AI-powered automation into these workflows, the platform allows pharmaceutical companies to navigate regulatory approvals with increased efficiency, reducing both costs and the risk of non-compliance. According to early adopters, the system has already delivered significant efficiency gains, enabling teams to reclaim hundreds of hours previously spent on manual compliance tasks.
Founders’ Vision for the Future
Entvin AI’s co-founders bring strong technical and industry expertise to the table. Speaking about the company’s vision, CEO and Co-Founder Sanskar Jain stated, “We identified a significant opportunity to transform how life sciences companies navigate regulatory requirements. Regulatory professionals spend countless hours on documentation, compliance checks, and staying updated with constantly evolving FDA guidelines. Our AI agents streamline these workflows, allowing teams to focus on strategic priorities rather than administrative burdens.”
Co-founder and Chief Product Officer (CPO) Hemant Phalak emphasized the seamless integration of AI into existing workflows, highlighting that the platform does not just organize information but actively identifies compliance gaps and automates repetitive documentation tasks. “At Entvin, our AI agents seamlessly integrate into existing workflows to enhance efficiency and accelerate decision-making. Our platform doesn’t just organize information – it actively identifies compliance gaps, automates repetitive documentation tasks, and provides regulatory teams with actionable insights in real-time. This helps life sciences companies navigate the approval process with unprecedented efficiency while maintaining trust, reliability, and seamless integration.”
Meanwhile, Co-founder and Chief Technology Officer (CTO) Rishabh Arya elaborated on the technical aspects of the AI system, stating, “We’ve developed an AI system that deeply understands the complex language of FDA regulations and can process massive volumes of regulatory documentation. Our architecture is enterprise-grade, designed to meet the highest compliance standards required by pharmaceutical companies, including SOC 2 and ISO 27001.”
Scaling for Global Impact
Entvin AI’s funding from Y Combinator provides the company with the resources to scale its operations, expand its AI capabilities, and drive customer acquisition in international markets. As mid-to-large pharmaceutical companies look for efficient and reliable ways to expedite their regulatory processes, Entvin AI is well-positioned to become a leader in the RegTech space for life sciences.
With the rise of artificial intelligence and automation across industries, regulatory technology solutions like Entvin AI’s platform are expected to play an increasingly crucial role in ensuring compliance while optimizing costs and efficiency. By addressing a pressing industry challenge, Entvin AI is not just simplifying regulatory work but also enabling pharmaceutical companies to bring life-saving treatments to market faster and more efficiently.
As the startup continues its growth journey, all eyes will be on Entvin AI to see how its technology transforms the future of pharmaceutical compliance in the years to come.
