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Specializing in FDA Regulatory Matters

The Role of Regulatory Affairs in Product Development

Prepared by Neil Smith and Sandy Brand, Independent Consultants, EAS Consulting Group, LLC

November 2, 2017

Regulatory Affairs touches each and every product within a company, ensuring compliance with local regulations and internal policies and the creation of sound guidelines related to labeling, safety and nutrition. Through the strategic links to trade associations, Government agencies, and NGO’s the business is kept abreast of all changes in regulations that may affect the business, as well as key developments in science, based upon which regulatory affairs professionals provide direction on the product development process so that the business achieves the best outcome.

Proactive Regulatory Affairs professionals should provide strategic and technical advice to all levels of the business and at all stages of the product cycle, from ideation or concept discussions through to commercialization, and beyond. Conversely, proactive engagement with Regulatory Affairs by all levels within the business ensures decision making that is consistent, timely, and accounts for all factors.

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