Ä¢¹½tv

Capabilities & Services

• Food Safety & Nutrition Regulatory Support

  Food and nutritional regulations are imperative when it comes to protecting human health and safety — from cross contamination and E. coli outbreak management to ensuring infant formula safety and school lunch guidelines. Ä¢¹½tv's scientists are internationally recognized experts in food science, risk assessment, microbiology, chemistry, nutrition, epidemiology, biostatistics, and product recall and regulatory support and can help you overcome a range of regulatory challenges.

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• Food Contact Materials Support

  Ä¢¹½tv's Chemical Regulation and Food Safety consultants have the expertise and experience necessary to support the regulatory and technical aspects of food contact material (FCM) regulatory submissions to the U.S. Food and Drug Administration (FDA), the European Commission, and the European Food Safety Authority (EFSA), as well as national agencies in the U.K., Switzerland, and other countries worldwide. We can assist FCM manufacturers in managing the compliance submission and review process, and users of FCMs to ensure the materials they source are compliant for the markets of interest. 

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• Claims on Foods and Dietary Supplements

  The use of health claims is of interest to both food and dietary supplement producers and consumers when there is a suspected relationship between a food substance and a health benefit. Ä¢¹½tv's Chemical Regulation and Food Safety consultants can assist in the development and substantiation of claims by locating, compiling, and critically evaluating relevant scientific literature, participating in regulatory strategy development, reviewing evidence, preparing documentation and petitions, and monitoring regulatory submissions.

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• Food and Nutrition Science Support

  Ä¢¹½tv provides experienced food science and nutrition consulting support for established food, ingredient, and beverage manufacturing companies, as well as start-ups, trade associations, and government clients.

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• Dietary Exposure & Human Health Risk Assessments

  Drawing on methodology that nutritionists, dieticians, toxicologists, epidemiologists, and biochemists have used for more than 60 years, dietary exposure assessments and dietary risk assessments are designed to evaluate human exposure to chemical, microbiological, or physical agents present in foods and to identify foods associated with an acute outbreak. Ä¢¹½tv has acquired and processed data from several national and international food consumption surveys and integrated them into models that can be used to efficiently estimate intake of foods, nutrients, and food additives (plus enzymes and flavorings), as well as dietary exposure to contaminants.

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• In Silico Toxicity Assessments - (Q)SAR

  Ä¢¹½tv has expertise in a variety of methods for in silico toxicity evaluations as well as toxicologists who can evaluate the implications of (Q)SAR outcomes.

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• Custom-Tailored Food Safety Programs

  The environment in which food companies and their suppliers operate is changing rapidly with more stringent regulations, increased demand for state-of-the-art food safety systems, and consumer trends toward more natural and organic products. Ä¢¹½tv offers custom-tailored food safety programs designed to meet your unique needs — from a single program to complete food safety evaluations, ensuring brands are free from harmful contaminants and microbes.

• GRAS Determinations and Regulatory Support

  Generally Recognized as Safe (GRAS) is an internal Food & Drug Administration term used to describe any food substance or food additive that has been adequately proven to be safe under the conditions of its intended use. GRAS classification for new food substances is only granted after proof of rigorous scientific procedures, and Ä¢¹½tv's Chemical Regulation and Food Safety experts provide flexible, responsive, and cost-effective reviews of all kinds of food ingredients, augmenting existing resources or offering turnkey GRAS assistance — including strategy, literature searches, data evaluation, expert panels, notifications, and FDA communications.

• Food Ingredient Product & Beverage Recall

  Ä¢¹½tv consultants leverage more than 50 years of extensive industry expertise helping ingredient, food, and beverage companies with recalls, determining if a recall is necessary, preparing for the recall, assisting in the decision-making for managing and terminating a recall, and providing support for interactions with regulatory and public health agencies.

• Risk Communication

  In crisis situations, sound, practiced, and thoughtful risk communication is required for preventing ineffective, incorrect, and potentially damaging results. Ä¢¹½tv's scientists, engineers, and physicians are professionally trained in risk communication and have years of experience communicating potential hazards to the lay public, news media, and government decision-makers, helping to ensure understanding of complex technical issues.

  Industry Analysis

  Foreign Materials Contamination in Packaged Foods

  A two-pronged incident response strategy for food manufacturers in the wake of prominent recalls.

  

• Due Diligence

  Focused on system and records reviews, due diligence is designed to identify and evaluate possible regulatory problems affecting company and product value. Because of the deep expertise and experience of Ä¢¹½tv's staff, due diligence work often includes not only a review of the current regulatory status of company products, but also an analysis of the anticipated future regulatory status of products, on a global basis. Often, such initiatives must be conducted within short time frames. The results of Ä¢¹½tv's due diligence projects provide critical information for our client's use in determining next steps in merger and acquisition initiatives.

• Summary of Services

  For 50+ years, we've thrived on solving unstructured problems that require bespoke solutions. Some of our services include:

  • Food product and non-food product safety evaluations
  • Dietary and nutritional assessments, including demographic factors and trends
  • Risk assessments of proposed additives, fortification, food contact materials, and nutraceuticals
  • Food labeling and health claims evaluation
  • Literature reviews
  • Nutrition epidemiology
  • Survey design and data analysis