Vision

To become the de facto standard for paperless or digitized validation life cycle management systems for operational processes across the life science sector.

Mission

To provide our clients with state-of-the-art, enterprise-wide software applications that manage and automate their validation processes to ensure compliance, improve efficiency, enhance data integrity, and significantly reduce validation cycle time to create significant savings in both time and cost.

Leadership Team

Before founding ValGenesis, Dr. Siva Samy held several technical and management positions at various biotech, pharmaceutical, and medical device companies in the fields of validation and Information technology. He has been credited with over fifteen research articles and holds a patent on ‘Validating and Maintaining Respective Validation Status of Software Applications, Manufacturing Systems and Business Processes’  by USPTO, and received a master’s degree in Analytical Chemistry, a Ph.D. in Medical Devices, and a post-doctoral from the University of Madras and University of Toronto.

Narayan Raj is responsible for managing ValGenesis’s worldwide sales, partnerships, and lead generation. Raj drives our company sales strategies, including new customer acquisition and expansion with existing customers. He has extensive sales experience in software solutions for regulated life science companies. He has held several sales management positions, including Sr. Director of Industry Solutions at Pilgrim Quality Solutions and Director of Pre-Sales at Infor.

As Vice President of Professional Services of ValGenesis, Robert Van Der Laan is responsible for managing ValGenesis’s Implementation and Professional Services group. Robert has over 15 years of experience identifying and solving customer information system needs, with the last eight years in leadership positions in enterprise system software companies. He drives customer satisfaction with the successful implementation of on-premise and cloud-based systems that provide tangible benefits in terms of lower costs, improved usability, and enhanced business intelligence. Robert has held several management positions including VP of Professional Services at Pilgrim Quality Solutions and Client Business Executive at Click Software.

Emmanuel Cansino has over fifteen years of experience in information technology and application development. Emmanuel has a proven track record of providing timely solutions to clients and translating business requirements to application enhancements. Over the past ten years, he has played a crucial leadership role at ValGenesis with significant involvement in the evolution of our VLMS system.

Dr. Ajaz Hussain is a distinguished contributor and acknowledged leader in the advancement of pharmaceuticals, regulatory science, and drug development. During Dr. Hussain’s tenure at the FDA, as Deputy Director, Office of Pharmaceutical Science, he led the FDA efforts on Process Analytical Technology (PAT) Initiative and CGMPs for the 21st Century. He was the FDA’s lead for Quality ICH negotiations and the establishment of ICH initiative on Pharmaceutical Quality for the 21st Century (ICH Q8, Q9, and Q10). He has served as the President of the National Institute for Pharmaceutical Technology & Education (a not-for-profit collaboration among leading American universities), as the principal of his consulting company Insight, Advice & Solutions. He has also held several senior management positions including CSO & President of Biotechnology at Wockhardt, Chief Scientific Officer at Philip Morris International, VP & Global Head of Biopharmaceutical Development at Sandoz, and Associate Professor of Pharmaceutics at the University of Cincinnati’s College of Pharmacy.

Pradeep has worked in diverse areas of product development, quality systems, computer system validation, process engineering, tool automation, and support functions in both the IT and manufacturing industries. He has a deep understanding of the life science domain and has supported pharma clients in optimizing and validating disparate systems through process design and computerization. His extensive knowledge of implementation in complex business processes, models with controls at the enterprise level, results in continual improvement, and effective risk governance. He has led and supported many global life science clients to optimize processes and build stronger solutions using LEAN & Six Sigma methods to reduce costs and improve compliance. Prior to ValGenesis, Pradeep was associated with Navitas Life Sciences Ltd. and Cognizant Technologies, providing solutions/support for top pharma organizations such as AstraZeneca, Abbott Laboratories, Pfizer, GSK, and Cipla in the areas of safety, quality, security, CSV, operations, customer support, and regulatory compliance.