FREMONT, Calif., Jan. 21, 2014 /PRNewswire/ —
ValGenesis, Inc., the market leader in Enterprise Validation Lifecycle Management Software solutions , today announced that Dr. Ajaz Hussain has agreed to serve as Senior Technical and Regulatory Advisor to ValGenesis. Regulated Life Sciences companies are required to plan, implement and document validation activities for every aspect of drug manufacturing and quality assurance. Most companies predominantly use manual, paper-based processes to manage the various activities needed to assure and document validation. ValGenesis – Validation Lifecycle Management System (VLMS) enables companies to manage their entire validation lifecycle electronically and eliminate the use of paper in this process. Furthermore, ValGenesis enables rigorous compliance, improving consistency, significantly reducing validation cycle time and removing inefficiencies that plague paper-based validation processes.
Dr. Hussain is globally recognized for his tireless efforts to improve predictability of medicinal product development, manufacturing and associated regulatory processes. As the Deputy Director Office of Pharmaceutical Science he led some of the U.S. Food and Drug Administration’s major initiatives to develop regulatory policies that already have, and will continue to have, a significant impact on product development and approval in many geographies. His corporate experience includes leadership of the development and/or regulatory submissions of first-in-class Biosimilar, Follow-on Protein and Complex Generic products at Sandoz. At Philip Morris International, he took on the challenge of higher levels of uncertainty (regulatory and business) and product complexity to build strategies and systems to successfully move forward development programs on plant-based vaccines, products for tobacco harm reduction, and ensure credibility of scientific evidence to seek regulatory discussions and submissions. His experience at Wockhardt has helped him to understand the opportunities and talent companies in India have, the challenges they face, and how they can bring forward effective solutions to maintain and enhance competitiveness and credibility. He also has an extensive teaching experience, he served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati, where he established a research program on Computer Aided Formulation Design. Based on his broad experience in academia, US FDA, and industry he founded his consulting practice Insight Advice & Solutions LLC.
Dr. Hussain will advise ValGenesis’s senior management team to facilitate their efforts towards delivering state-of-the-art ValGenesis VLMS. Specifically his contributions will help to align further evolutions of ValGenesis VLMS to proactively deliver emerging regulatory requirements in the US and Globally.
“The ValGenesis VLMS is a trusted platform for many global Life science companies to manage their validation process. ValGenesis is excited to have Dr. Hussain in the advisory board. Dr. Hussain is one of the architects for science-based approaches to quality and compliance at FDA. His expertise and experience as Deputy Director of FDA, as a life sciences commercial executive, and as an industry consultant will help to evolve ValGenesis VLMS on par with evolving regulatory requirements and industry needs. We strongly believe that this collaboration will help ValGenesis VLMS become a de-facto standard on how Validation Lifecycle should be assured and managed across the global life science companies,” said Siva Samy, Ph.D., Chief Product Strategist & CEO of ValGenesis, Inc.
“As a first mover in the market, ValGenesis is demonstrating the value of the electronic validation lifecycle management system to global life science companies. Companies adopting ValGenesis are realizing significant improvement (consistent compliance and cycle time reduction) in their validation processes. With increasing regulatory focus on science based validation, to ensure an adequate level of statistical confidence, I expect the ValGenesis software solution will be invaluable in implementing rigorous validation. I am excited to support ValGenesis in their continual efforts in pursuit of excellence. This is an exciting opportunity to anticipate the evolving regulatory requirements and help to define the best practices for ValGenesis VLMS so that life science companies can more confidently deliver high-quality products, on time, to patients around the world,” remarked Dr. Hussain.
About Insight, Advice & Solutions
IAS offers clear insight, expert advice, and effective solutions to the private and public sectors. Our core focus is efficiently developing and upholding credible scientific evidence to support product development, improve manufacturing and quality assurance, and reduce overall risk and uncertainty. Via this focus, we offer services to create sustainable competitive advantage and cost savings to our clients.