A team of Highly Experienced Professionals
Who we are?
We are a group of professionals with more than 70 years of combined experience in the areas of Quality System management, Quality Engineering, Regulatory compliance.
We have real world work experience from many different regulated industries that includes Medical device, Pharmaceuticals, Consumer product manufacturing.
Over the years we have experienced the challenges, the pains the users have when using the off-the-shelf computer software for Quality Management Systems (QMS). The systems which are currently available in the market are complex, time taking for implementation, and expensive too. The users need lot of training to use the systems. The users are always fearful when using these systems. These systems need lot of administrative supports as well.
70+
Years of experience
1000+
Successful cases
100+
Industry awards
Our Vision
Our Leadership Team:
Sanjay is a Quality and Regulatory Management Professional with more than 20+ years of experience in Quality Management roles including QMS, Quality Engineering, Regulatory Compliance and Operational Excellence in the Life Science industry. Prior to Qualcy, Sanjay worked with Becton Dickinson (BD), Ablestik Laboratories and Unilever Group companies. Sanjay has worked with 150+ Bio-Med and Life Science Companies for QMS and CMMS Software Solutions. He has strong knowledge and expertise in the FDA Regulations including 21 CFR 820, 21 CFR 210, 21 CFR 211, 21 CFR Part 11 compliance requirements. He has been a trusted advisor for many Medical Technology and Life Science companies.
Sanjay is a recognized leader and author in the QMS and Regulatory Compliance areas and holds following certifications from American Society of Quality (ASQ). He is a Certified Six Sigma Black Belt (CSSBB), Certified Quality Engineer (CQE), Certified Quality Auditor (CQA) from American Society for Quality.
Sanjay holds MBA (from San Diego State University), MS in Industrial Engineering from Wichita State University, BS (Chemical Engineering) from National Institute of Technology, Rourkela, India.
Outside the work, Sanjay is busy with his two young boys at the neighborhood parks and beaches.
Experienced Business Development Professional with more than 25+ years’ experience in the Life Science and Consumer Industries. Yomi has strong expertise in understanding the customer expectations and formulating solutions to meet the business needs. He is appreciated by the customers for his patience and business acumen. Yomi combines years of operational experience with financial models to develop realistic business proposals. Prior to Qualcy, Yomi worked with Becton Dickinson (BD), Henkel, Loreal, and Unilever group in the areas for business development and operational management.
Yomi holds MBA from Saint Peters University and BS from Kent State University.
When Yomi is not at work, he is passionate about photography and writing stories. He has published many short stories and books. He is planning to direct and make his own movies someday.
