Christopher W.McDaniel, Ph.D., brings 25 years of experience in the pharma, OTC, and dietary supplement/nutraceutical industries to his consulting practice. He has served as Vice President and Chief Scientific Officer with experience in the pharmaceutical, OTC, dietary supplement and nutraceutical industries leading over 100 direct and indirect reports. He is a product developer with R&D experience in multiple formulation platforms and routes of administration leading to successful launches of five NDA products and more than 20 OTC, dietary supplement, nutraceutical, and personal care products.
He has proven experience in managing quality systems with successful inspections by FDA, international regulatory agencies, and client companies. He developed a risk-based rating system for internal manufacturing, raw materials, raw material suppliers, and contract manufacturers to prioritize focus in the management of over 100 suppliers and contract manufacturers.
Dr. McDaniel has expertise in regulatory compliance and product registrations internationally. He has functioned as the executive lead and team member in face to face meetings with US and foreign health authorities.
He has been successful with medical affairs and clinical trials serving as a executive lead or team member in the planning and/or execution of more than 70 clinical trials Phases I – IV. Other studies he has been responsible for are in the area of claims support and safety in OTC and personal care products. His experience includes leading the global pharmacovigilance and safety reporting function.
As team leader and team member in acquisitions, Chris helped conduct the search for, due diligence, and integration of acquired companies, brands, and technologies. He participated as a team member in the divestiture of companies and products ensuring the strategic goals of the company are met.