SUMMIT, N.J.--(BUSINESS WIRE)--Hurley Consulting Associates Ltd., a leading international drug development consulting company recognized for its high level of regulatory expertise, announces the appointment of John C. Talian, Ph.D., as Vice President of Regulatory Affairs. Dr. Talian is responsible for developing regulatory strategies, providing regulatory analyses, managing regulatory interactions with the FDA, and preparing dossiers for global submission to health authorities. He will advise clients in the design, development and strategic planning and implementation of regulatory programs in light of health authority requirements. He will also assess clients' existing development programs.
"Dr. Talian's regulatory expertise and experience is a valuable addition to Hurley Consulting's strength in providing clients with sound regulatory advice and input based on years of experience in the regulatory arena," said Susan M. Mondabaugh, Ph.D., Vice President, Regulatory Affairs.
Dr. Margaret E. Hurley, President and CEO of Hurley Consulting Associates, commented: "Dr. Talian's depth of knowledge and more than twenty years' experience in the pharmaceutical industry strengthens the strategic capabilities of the company and allows us to continue to provide our clients the highest quality of regulatory advice."
Dr. Talian's broad expertise as a senior global regulatory leader includes many aspects of the drug development process from regulatory development to registration and life cycle management of novel therapeutic compounds in the global marketplace. Dr. Talian has significant experience in multiple therapeutic areas including oncology, cardiovascular, CNS, metabolic-endocrine and blood products.
Before joining Hurley Consulting, Dr. Talian was Vice President, U.S. Head of Regulatory Affairs, Global Regulatory Affairs, at Bayer Healthcare Pharmaceuticals, where he led a staff of 80 professionals with both domestic and global responsibilities for development projects and marketed products. He has also held positions at Hoffmann-LaRoche Pharmaceuticals and R.W. Johnson Pharmaceutical Research Institute.
Dr. Talian holds both a bachelor's and doctoral degree in Cell and Molecular Biology from Carnegie-Mellon University.
"I am really happy to be joining Hurley Consulting at this exciting time of change within the industry. The new legislation and initiatives in the US and around the world present unique challenges. I look forward to adding my knowledge and experience to our strong Regulatory team in finding solutions for our clients," said Dr. Talian.
Based in Summit, NJ, Hurley Consulting Associates Ltd. was founded in 1987. The company specializes in finding solutions for its clients' regulatory and commercial development needs. With unique expertise to prepare global regulatory submission documents and dossiers, Hurley Consulting integrates nonclinical, clinical, and manufacturing and control evaluations, performs data analyses, and develops and implements regulatory strategies. With a proven track record of twenty-five years' regulatory experience, Hurley Consulting can serve its clients as U.S. agents and authorized representatives to the FDA for regulated products for the entire IND through NDA process. www.hurleyconsulting.com
Hurley Consulting Associates Ltd.
Zina Suriano, 908-273-8490