TSG

FDA - Drugs & Devices

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FDA OVERVIEW

FOOD, DRUGS, COSMETICS AND MEDICAL DEVICES

Technology Sciences Group Inc. (TSG) provides scientific and regulatory advice in the areas of foods, food packaging, human and veterinary drugs, cosmetics and medical devices. TSG staff include experts in the scientific and regulatory disciplines necessary to issues in these areas and, if necessary, to obtain regulatory solutions.

TSG staff can assist with negotiations with and submissions to the appropriate Centers within FDA. TSG scientists can provide advices regarding data needs, laboratory selection, contracting and production of studies, compliance with Good Laboratory Practices and Good Manufacturing Practices, and submissions of all types to the FDA. We are familiar with state-of-the science methodology for the assessment of safety and efficacy. TSG scientists are also available to provide expertise in addressing concerns of the European Food Safety Agency and the Joint FAO/WHO Expert Committee on Food Additives and Contaminants (JECFA). TSG can, with the assistance of TSGE, our European Affiliate, prepare dossiers and other submissions for the EU competent authorities.

TSG regulatory specialists will be pleased to assist in developing regulatory strategies and preparing notifications for Food Contact Substances and GRAS chemicals, petitions for food ingredients and color additives, 510(k) submissions, NDAs, INDAs, veterinary drug applications and other submissions for substances or agents regulated by the Food and Drug Administration. TSG can also act as the US agent for companies with FDA-regulated products.