FDA Regulatory Compliance Consulting Services | Who We are!

As a researcher and statistician with wide-ranging experience including both qualitative and quantitative research, Dr. McGill has worked for the past 30 years in both B2B and B2C environments conducting primary and secondary research.

Having spent 15 years in the healthcare arena and 16 years in market research, he is adept at selecting and applying the best methodologies and statistical analyses from either industry. Most recently, Dr. McGill has focused his attentions on the development and marketing of new products in healthcare while emphasizing consumer perceptions and behavior, and marketing strategy.

Dr. McGill’s work experience includes three (3) years as a Biostatistician for the Medical College of Wisconsin, six (6) years as an Analyst Specialist for Denver Public Health including work with the CDC, and sixteen (16) years as a market research consultant.

Dr. McGill has significant experience as a statistician having run a wide range of statistics depending upon the industry—ANOVA, CHAID, Chi squares, Cluster, Conjoint, Factor, MaxDiff, Regression in its various forms, and Survival Analysis, among others.

Dr. McGill holds a PhD in Health and Behavioral Science from the University of Colorado- Denver, and an MS in Research Psychology from Saint Louis University.

Dr. McGill has co-authored a number of peer-reviewed journal articles including publications focused on new devices for Dry Eye Disease, and a Point-of-care wound reporting system for user satisfaction and improved patient care, and most recently “Firms that Prosper in all Weathers: Surviving Recessions and Plagues” in the Journal of Business Strategy.

Where appropriate, Dr. McGill strives to bring behavioral science into the mix—humanizing and enhancing consumer insights and marketing strategies.

[vc_row][vc_column][vc_column_text css=”.vc_custom_1620308571233{padding-top: 80px !important;padding-right: 80px !important;padding-bottom: 80px !important;padding-left: 80px !important;}”]Dr. Rakesh Guduru has years of experience in evaluating ENDs products to understand toxicological implications. He has started his carrier as a Lead Research Scientist in South Florida’s biggest E-cigarette manufacturer. Later he joined as a Director of Research and Scientific Affairs at Turning Point Brands a leading manufacturer in Other Tobacco Products. He is also a committee member for UL 8139 Standard (Electrical Systems of Electronic Cigarettes and Vaping Devices). Below are some of his detailed expertise.

1. Evaluation of the toxicity of the individual chemical ingredients used in the manufacturing of the vape product.
2. Each ingredient is assessed for its hazard or “inherent” toxicity such as acute toxicity, respiratory irritancy, aspiration toxicity, inhalation toxicity, reproductive toxicity, genotoxic, or carcinogenic activity, in relation to the potential for consumer exposure to the chemical.
3. Predictive modeling data (based on Tanimoto Similarity Value Distribution) for above listed toxicological endpoints if the ingredient does not have toxicological data.
4. Determines pyrolysis by products of the chemical ingredients. i.e., compounds formed due to burning of the chemical ingredients. Helps assess the toxicological risk due to burning of the product.
5. Potential for synergistic or unpredictable adverse effects from the combination of ingredients in the formulation.
6. TRA based on daily inhalation of vape product for low, mid, and high users.
7. Evaluates TRA based on margin of exposure (MOR) and Permissible Daily Exposure Limit (PDE).
8. Classifies the final product Hazard based on GHS classification and recommends packaging compliance guidance and recommends mandatory label requirement.

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