BIOSTRATEGY INC. provides strategic guidance in drug registration from the start of clinical planning to launch and beyond.
Rapid changes in technology, regulatory requirements, and competition demand that companies strategically plan their course in drug registration for pipeline molecules well in advance to achieve faster time-to-market.
At Biostrategy Inc., we believe that early and appropriate planning is key to success for our clients. As well, the proper execution of the registration plan is vital.
The Biostrategy team members have extensive North American strategic planning and regulatory driven development experience. We can provide your company with timely, state-of-the-art services of a complete regulatory affairs department.
Management Team
David C. Leung, M.Sc.Phm., Founder and Managing Director
David has over 25 years experience in the Pharmaceutical Industry in Canada. Before he established Biostrategy, he worked for two major multi-national pharmaceutical companies, first at Bayer Inc. from 1980 to 1990, and then at Pharmacia Inc. from 1990 to 2000. At Pharmacia he held the position of Vice President, Regulatory Affairs and Quality Assurance and was a member of the Executive Committee.
David was responsible for the registration of numerous major pharmaceutical and biopharmaceutical products in the cardiovascular, anti-infective, metabolic diseases, oncology, ophthalmology, urology, critical care, and women's health areas. He is also familiar with the regulatory systems in the U.S.A. and Europe.
David's key areas of responsibility at Pharmacia included the development of both short and long-term regulatory strategies, project management, regulatory compliance, and quality assurance. For a number of years, he chaired the project action committee of the company, and served in various capacities in committees for a number of trade associations. He also held the position of acting Vice President, Medical Affairs and Health Economics for a period of two years..
Prior to his involvement with multi-national companies, David was Director of Development for an international consulting firm. In this capacity, he was involved in international data evaluation, multiphase development planning, clinical research management, co-ordination of expert focus groups, and market research. David obtained his Master of Science degree in Pharmacology at the University of Toronto.
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Chao H. Chang, M.Sc.Phm., Director, Operations Chao obtained his Master of Science degree in Pharmaceutical Science at the University of Toronto. Over the course of his career he held senior positions in several major pharmaceutical companies in the area of manufacturing both in sterile and non-sterile products, including the position of Director of Manufacturing at Sterilab Ltd. He was Managing Director of Bioceutical Research Ltd., a company involved in pre-clinical animal testing of pharmaceuticals, in the 1980's, and later formed his own company Chang Bio-Medical Consultants Inc. in the 1990's. He joined Biostrategy in 2001 and has held the position of Director, Operations since its inception.
Cecilia S. Tam, B.Sc.Phm., Director, Health Products Cecilia graduated from the University of Toronto Faculty of Pharmacy and had a long career in retail pharmacy. She achieved success and garnered recognition in the community as the manager of two large chain pharmacy operations, and as the owner and operator of two independent pharmacies and a medical centre. She is a consultant in disease management and an expert in naturopathic and herbal medicine. Cecilia joined Biostrategy in early 2006 and assumed the responsibility of managing the Natural Health Product development and registration business. She also took on the responsibility as manager of regulatory affairs in the company before her current role as Director, Health Products.
Albert P.N. Chan, M.Sc. (Chem.), Director, Asia Pacific Region Albert is a graduate of the University of Manitoba, Canada with both a Bachelor of Science Honors degree and a Master of Science degree in Chemistry. He served as a Quality Control Manger in the Pharmaceutical Industry before returning to his home in Hong Kong where he established his own company, M&S Industries Ltd. In the next 20+ years, he successfully developed sales of a series of food and flavour ingredients into China and Southeast Asia. He also expanded his company and established flavour manufacturing facilities in different parts of China, and also a R&D facility dedicated to the advancement of Gum Technology. One of his many successes includes purifying a China-produced konjac flour into different types of konjac gums and exporting these products into the USA and Europe, both as a food ingredient, and as health food products, through his two subsidiary companies, M&S Gum Technology Ltd., and M&S Health Food Ltd. Albert is currently managing the development of Biostrategy’s Asia Pacific business. He is also the 2008-9 Chairman of the Hong Kong Food Sciences & Technology Association. He is a part-time lecturer of the Master of Science Program in Food Management and Marketing at the University of Hong Kong Botany Department, and Technology Consultant of Gum Technology Asia, Biostrategy Life Science Management, and M&S Gum Technology Inc.
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