Susan MacIntosh is the Founder and President of an independent consultancy MacIntosh & Associates, Inc. formed in July 2005, celebrating its 10-year anniversary this summer. The firm focuses on biosafety compliance services for clients developing biological-based products for the agricultural market. Strategic support, technical expertise, and regulatory services are provided to advance products from initial research stages through development onto commercial release and post-marketing requirements with special attention to compliance with government regulations at all stages.
The founder of the firm, Sue MacIntosh, is a scientist with 20 years of regulatory experience and more than 40 years of research and development experience in the biotechnology field. Sue has worked at the leading edge of agricultural biotechnology innovation, pioneering the development of the first transgenic plants since the late 1980s. After her research supported the first commercial product development, Sue moved into the regulatory affairs arena where she obtained and defended a range of product registrations. She has worked in Australia, Japan, Korea, India, Indonesia, Costa Rica, the European Community, Argentina, Brazil, Mexico, USA and Canada. Prior to her founding of MacIntosh & Associates, she was Vice President in charge of the global biotechnology regulatory affairs function at Bayer CropScience. Her experience spans success in both public and private sectors, from small start-up companies to major multinational companies. Sue's current clients cover the same broad spectrum.
Sue is a co-founder of ABTR Network.
Global Regulatory Lead for Nuseed Americas
Writing, review and editing of technical and regulatory submissions, including submissions to FDA, USDA, and EPA
Representing international companies to gain EPA approvals for various biopesticide products
Regulatory management and process improvement in Asia-Pacific region
Successfully obtained permits and performed audits for plant-made pharmaceutical and plant-made industrial crop field trials
Obtained 14 registrations on behalf of Pasteuria Bioscience, Inc. now wholly owned by Syngenta Crop Protection
Technical assistance for protein safety and potential allergenicity assessment
Technical and regulatory advisor for start-up biopesticide companies
Various training programs for: Food and Feed Risk Assessment, including Potential Allergenicity; Field Trial Compliance; US Regulatory Process and Management
USAID funded training program in Indonesia for conduct and biosafety of field trials