Sanjay Dhal

About Sanjay Dhal

Your pharma company is spending 30-40% of its operational resources on regulatory compliance work that could be automated.I know this because I spent 20+ years inside the industry watching it happen at every level, from site operations to enterprise quality systems.The manual monitoring. The siloed investigations. The same root causes surfacing in deviation after deviation, CAPA after CAPA which are never connected, never resolved at the system level. And then the Warning Letter arrives.I\'ve spent two decades in pharmaceutical regulatory and quality operations, including my time at BD (Becton Dickinson), one of the world\'s largest medtech and pharma companies. During my time at Qualcy I\'ve worked with compliance teams. I\'ve led quality system implementations. I\'ve seen what inspection-ready looks like and what it doesn\'t.I\'ve also built regulated-industry software before, founding Qualcy Systems to serve pharma quality teams. I understand both sides: the operational reality your compliance team lives in every day, and the technology that can change it.That combination with deep pharma regulatory domain expertise plus hands-on product building is what I focus on at Regulys.We have built Regulys to solve the problem I watched go unsolved for 20 years.Regulys is an AI-powered regulatory intelligence platform that monitors FDA and EMA activity in real time, connects compliance signals across your quality system, and cuts the manual overhead that consumes your best people by 40-60%.We work with enterprise pharma companies who are done reacting to regulatory changes after the fact and ready to get ahead of them.If you\'re a VP of Regulatory Affairs, Head of Pharmacovigilance, or Chief Compliance Officer and your team is spending more time managing compliance noise than driving compliance outcomes, then DM me the word COMPLIANCE and I\'ll show you exactly how Regulys works in 20 minutes.

Experience

1. Cofounder and CEO

   Qualcy Systems Inc

   Jun 2018 — Present · San Diego, US

   Founded Qualcy Systems to bring structured quality management software to pharmaceutical and regulated-industry organizations that were still running critical compliance processes on spreadsheets, paper-based systems, and disconnected tools.At Qualcy I built a regulated-industry software company from zero - understanding what pharma quality teams actually need from a technology platform, where implementations succeed, and where they fail.• Established effective Regulatory Compliance and Quality Management Systems for Bio-Med companies to improve productivity and achieve compliance.• Helped 150 plus companies enhance RC and QMS effectiveness with innovative solutions.• Leading the planning and delivery for Quality and Compliance Solutions, focusing on customer experience

Education

• Wichita State University

  MS, Industrial Engineering

  2002 — 2004

• San Diego State University

  Master of Business Administration (M.B.A.), Business Administration, Management and Operations

  2010 — 2012

• National Institute of Technology Rourkela

  Bachelor’s Degree, Chemical Engineering