Navigating complex food safety and regulatory issues
Food safety programs
The environment in which food companies and their suppliers operate is changing rapidly with growing consumer demand for natural and sustainably sourced food products, more stringent regulations, and increased demand for state-of-the-art food safety systems. Ä¢¹½tv offers a variety of customizable food safety services, from addressing an urgent need for a complete third-party food safety evaluation to ensuring that brands are protected from harmful contaminants and microbes and comply with regulations.
Ä¢¹½tv's scientific and regulatory consultants can conduct vulnerability assessments of regulatory and safety systems, perform safety assessments and compliance audits, and manage due diligence processes from start to finish. We conduct in-plant evaluations for food hazard identification, Good Manufacturing Practice (GMP) compliance, and Hazard Analysis Critical Control Point (HACCP) adequacy. In addition, we review process and quality systems documentation, validate preventive control technologies, review Food Safety Modernization Act (FSMA) preparedness, and develop process models to verify product safety. Often working with our clients' in-house technical staff, internal counsel, or external law or insurance firms, Ä¢¹½tv provides the scientific, technical, and regulatory capabilities needed for time-sensitive and issue-sensitive work that is critical for business success.
Regulatory support
In today's evolving regulatory environment, food and beverage companies, and departments and agencies need experienced advisors who can navigate through complex food and ingredient compliance necessities. Our experts support safety assessments for food and color additives, generally recognized as safe (GRAS) substances, food contact substances, and newly introduced dietary ingredients, and provide dietary intake estimates in the U.S., EU, and other countries to support regulatory submissions and other safety assessments of various food components. In addition to regulatory support on behalf of our clients, our consultants also prepare scientific substantiation for claims related to health, nutrient content, and structure/function.
Whether in a food plant or on a national or international regulatory strategy committee, our scientific and regulatory consultants have the knowledge and experience to efficiently address your most pressing pre- and post-market needs. Our project experience includes foods and beverages, dietary supplements, novel foods, medical foods, infant formula, and bottled water. With a multidisciplinary team including medical, human factors, public health, and nutrition experts, we also have the expanded capability to evaluate consumer behavior, intake and exposures, and adverse reactions.
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Services
For 50+ years, we’ve thrived on solving unstructured problems that require bespoke solutions. Some of our services include:
• Response to regulatory inspections, investigations, and warning letters
• Performing health hazard evaluations on microbial, chemical, and physical hazards
• Outbreak investigations reviews
• Assist in recall decision making and management
• Pre- and post-incident assessments of food safety management systems
• Root cause analysis
• National and international regulatory strategy support
• Safety assessments for food and color additives, GRAS substances, food contact materials, novel foods, and new dietary ingredients
• Dietary intake estimates for the U.S., EU, and other countries
• Scientific substantiation for claims, including health, nutrient content, and structure/function claims
• Compliance guidance and support, including regulatory submissions
• Expert and technical support for dietary exposure assessments under California's Proposition 65
Our Capabilities Are Unparalleled
With expertise in over 90 disciplines and hundreds of capabilities, tools, and methodologies — we get to the root of even the most complex challenges and give you the objective answers you need.
Food
Food safety, nutrition, and dietary exposure assessments, and technical and regulatory support.
Biocides & Antimicrobials
Expertise in multifaceted regulatory requirements in biocide and antimicrobial product approval processes.
Agrochemicals & Pesticides
Navigate complex requirements for agrochemicals and pesticides in Europe and North America.
Consumer Products: Cosmetics & Personal Care
Personal care products consulting for registration, notification targets, and product development.
Industrial Chemicals
Regulatory support for chemicals, solvents, polymers, antimicrobials, biocides, and more.
Experts
Our global and comprehensive expertise across industries gives us a deep understanding of current challenges, best industry practices, and the implications of emerging technologies.
Practice Director and Principal Scientist