Timothy A. Dotson, M.S. Email & Phone Number

Sugar Hill, Ga

RCS is an integrated regulatory consulting firm providing customized solutions for your regulatory needs for EPA pesticide products and FDA/Center for Veterinary Medicine (CVM) new animal drugs. Our dedicated staff has 20+ years in the pesticide and animal health industries. From the most basic to more complex strategies, we have the skills to successfully get your product through the regulatory process in a timely fashion. Our knowledge of the laws and regulations governing pesticides and new animal drugs, combined with years of practical experience working with federal, state and local agencies, will help your company avoid the regulatory pitfalls that cost time and money. At RCS, our goal is to streamline the regulatory process and get your product to market sooner. Call us at 404-698-7199 or email at tim.dotson@regcompliancesolutions.com for more information. Also see website for more details: http://www.regcompliancesolutions.com

Burlingame, California

As Director of Regulatory Affairs managed all aspects of FDA approval for new animal drugs, including small molecules and biologics. Managed regulatory personnel and coordinated timely submission of new animal drug technical sections to FDA/CVM. Participated in Management Steering Committee meetings to discuss regulatory issues that may affect the business. Developed post-approval processes and SOPs for anticipation of the company’s first FDA/CVM approval, a new animal drug for control of pyrexia in horses. Asked to lead company in all post-approval regulatory activities, including creation of a new post-approval regulatory group. Developed the company’s first EU marketing authorisation for a new animal drug for control of weight loss in cats. Liaison for both EMA and the FDA/CVM in all matters related to both EU and US submissions.

San Francisco Bay Area

As Executive Director of Regulatory Affairs & CMC I managed all aspects of FDA approval for new pharmaceutical products in an animal health company specializing in botanical drugs used to treat gastrointestinal conditions in dogs, cats and horses. Point of contact with FDA/CVM for managing all aspects related to filing and approval of new pharma projects. Achieved Minor Use, Minor Species (MUMS) determination for the use of crofelemer in treating dogs with chemotherapy-induced diarrhea.

Duluth, Georgia

As Director of Regulatory Affairs US, I managed all EPA projects in addition to new pharmaceutical projects in a leading global animal health company. Active in project teams for development and submission of pesticide applications to the US EPA, and technical sections for New Animal Drug Applications (NADAs) to the FDA/CVM. Obtained EPA approval for two new end-use products and one manufacturing-use product, in addition to numerous new clinical efficacy and safety claims for the FRONTLINE brand of products. Achieved FDA/CVM approval for two equine drug products in addition to NEXGARD soft chewable for fleas and ticks. For EPA and new pharma projects, collaborated with R&D, CMC, Safety Assessment, Industrial Operations, Manufacturing, Quality Assurance, Supply Chain, Formulations Development, Analytical R&D, and Clinical Operations.

Marietta, Georgia

Managed day-to-day regulatory affairs operations of a $28MM global division specializing in the manufacture and sale of commercial and specialty pesticides and industrial amines. Liaison for various government authorities including US EPA, FDA, USDA, DEA, etc. Over 12 years of experience involved in management of international, federal and state pesticide registrations, risk assessment and toxicology, including consulting experience for agrochemical, chemical, and pharmaceutical companies. Served as company representative in 7 distinct roles for 5 pesticide industry consortiums. Responsible for NA regulatory affairs division with interactions with Latin American Region, Canadian and European affiliates.

Ms, Toxicology, 3.8/4.0

B.S., Microbiology