Lauterbach & Associates, LLC, was founded October 1, 2004, to provide scientific and regulatory affairs (S&RA) services to smaller tobacco companies, provide chemistry and toxicology services to local industry, and keep the owner sufficiently involved in toxicology to maintain his Diplomate of the American Board of Toxicology credentials. Original objectives were met, except for services to local industry (no market.) However, a new market opened: writing manuscripts for clients that made oral presentations, but lacked staff to engage the writing and editorial process. This service enhanced our marketing efforts, added to our work portfolio, and allowed us to start our internal research program on non-cigarette tobacco products. 2009 was a breakthrough year, with appointment of an independent sales representative, and codification of federal regulations on tobacco products. 2011 brought a three-year term on the FDA's Tobacco Products Scientific Advisory Committee and becoming top independent provider of S&RA services for companies required to file FDA 905(j) Substantial Equivalence reports. Bust followed the boom, and we shifted our efforts to the scientific side of the e-cigarette business, obtaining new clients and increasing our participation on relevant technical committees. This presentation will focus on the underlying business decisions needed to react to the marketplace and ensure sufficient capacity for increases in the business caused by changes in governmental regulations.

Celebrating ten successful years at Lauterbach & Associates, LLC

248th National Meeting (2014)

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