Tunnell Consulting, Inc. today announced that it has established a multi-year collaboration with Ajaz S. Hussain, Ph.D. and his consultancy Insight, Advice & Solutions (IAS) LLC to deliver product development, quality assurance and regulatory compliance solutions to life sciences companies. Together, Tunnell and IAS will collaborate on evolving business and operational processes to deliver state-of-the-art drug development and quality and compliance solutions for clients both domestically and internationally.
At the U.S. Food and Drug Administration (FDA), Dr. Hussain led some of the major initiatives to develop risk- and science-based regulatory policies such as Quality by Design (QbD) and Process Analytical Technology (PAT). He was also the FDA's lead for quality in the negotiations for the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use and for the ICH Initiative on Pharmaceutical Quality for the 21st Century, including ICH 8, ICH 9 and ICH 10.
Tunnell Consulting, which has long embraced risk- and science-based approaches to quality and compliance, brings to the partnership its operational expertise, comprehensive understanding of technical issues, and extensive experience designing practical, value-add sustainable solutions for leading life sciences organizations. Tunnell and IAS will offer clients traditional as well as groundbreaking solutions designed to pre-empt future challenges, remediate existing problems, and establish operational excellence in quality and compliance.
"Tunnell Consulting is delighted to partner with Dr. Hussain, one of the genuine trailblazers in science-based approaches to quality and compliance," said Conrad J. Heilman, Jr., Ph.D., President and CEO of Tunnell. "His expertise and experience as an FDA official, as a life sciences commercial executive, and as an industry consultant complement Tunnell's longstanding strengths in quality and compliance and demonstrated ability to deliver sustainable results. Together, we will be able to provide clients with mutually reinforcing improvements in business and technical operations that take their organizations to the highest levels of excellence."
"This is an exciting opportunity to co-develop unique business, regulatory and compliance solutions for our clients with a clear focus on delivering business success. Given the increasing complexity and uncertainty in the life sciences business there are significant opportunities for companies that are focused on customer satisfaction to create and leverage competitive advantage. This collaboration will allow IAS and Tunnell to help their clients in the US and abroad to leverage these opportunities," remarked Dr. Hussain.
Prior to founding IAS, Dr. Hussain served as President of Biotechnology and Chief Scientific Officer for Wockhardt LTD. Previously, as the Chief Scientific Officer and VP, Next Generation Products at Philip Morris International, he built strategies and systems to advance development programs on plant-based vaccines and to ensure credibility of scientific evidence for regulatory discussions and submissions.
As Vice President and Global Head of Biopharmaceutical Development at Sandoz AG, he led the development of and regulatory submissions for first-in-class biosimilar, follow-on protein and complex generic products, successfully navigating uncharted organizational, legal and regulatory territory.
Dr. Hussain also has extensive teaching experience and had served as a tenured Associate Professor of Pharmaceutics at the University of Cincinnati where he also established a research program on Computer Aided Formulation Design.
About Tunnell Consulting
Founded in 1962 and serving many of the world's leading life sciences firms and government agencies, Tunnell Consulting, Inc. integrates strategic, technical and regulatory compliance skills to design and implement sustainable solutions that exactly meet client needs. With deep industry knowledge, extensive scientific and compliance credentials, and superior measurable results, we consistently boost the operating performance of each unique client we serve.
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.