Scientific Expertise. Regulatory Precision. Trusted Results.
Burdock Group is a science-driven regulatory consulting firm dedicated to helping companies bring safe, compliant products to market.
With over 30 years of experience, we are the partner of choice for clients navigating complex FDA, EPA, and USDA regulations. Our team of expert toxicologists, scientists, and regulatory professionals provides tailored solutions across the food, beverage, dietary supplement, animal feed, cosmetics, and pesticide industries.
Whether you’re introducing a new ingredient, formulating a pet food, registering a sanitizer with the EPA, or validating a structure/function claim, we guide your product from concept to compliant commercialization—backed by science and aligned with global regulatory standards.
FOOD & BEVERAGE
Safety assessments and regulatory compliance in the food and beverage sector require a methodical, science-driven approach to meet the rigorous standards set by the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA). These agencies establish detailed frameworks to ensure product safety, covering everything from ingredient sourcing to final distribution, with strict guidelines on acceptable limits for contaminants, additives, and labeling accuracy.
Systematic evaluations involve analyzing products for potential hazards, such as microbial contamination, chemical residues, or allergen risks, using data-driven methods like lab testing and risk modeling. Compliance with USDA and FDA regulations demands navigating multifaceted requirements, including Good Manufacturing Practices (GMPs), Hazard Analysis and Critical Control Points (HACCP) protocols, and specific labeling mandates, such as nutritional content and allergen declarations.
Support in product development, accurate labeling, and adherence to regulatory landscapes is crucial for market success. Science-backed strategies, rooted in food science principles, help ensure products not only meet but exceed safety and compliance standards, addressing challenges like evolving regulations and consumer safety expectations in the competitive food and beverage industry.
PET FOOD & ANIMAL FEED
Food safety and regulatory compliance in the Animal and Pet Feed sector demand a deep understanding of evolving standards and challenges. The Association of American Feed Control Officials (AAFCO) and the Food and Drug Administration (FDA) establish intricate regulations that ensure animal well-being and industry success, requiring meticulous attention to detail and up-to-date knowledge.
Navigating this complex landscape involves addressing unique sector-specific risks through thorough assessments and tailored solutions. Staying ahead of regulatory changes and industry trends is essential, as is adapting to the latest scientific insights to meet compliance requirements effectively.
Adherence to AAFCO and FDA guidelines is critical for protecting animal health and supporting business growth in this field.
Comprehensive consulting services, grounded in regulatory insight and a focus on animal welfare, play a key role in driving excellence and maintaining high safety standards in the Animal and Pet Feed industry.
DIETARY SUPPLEMENTS
The dietary supplements and functional foods sector has experienced significant growth over the past 30 years, emerging as one of the most dynamic areas within the food industry. This expansion is driven by increasing consumer demand for health-enhancing products, alongside a complex and evolving regulatory landscape that governs their development, safety, and marketing.
Navigating this landscape requires a thorough understanding of safety assessments and compliance requirements, which are shaped by regulations from agencies like the FDA. These regulations cover aspects such as ingredient safety, health claims, and labeling accuracy, often involving detailed processes like New Dietary Ingredient (NDI) notifications and Generally Recognized as Safe (GRAS) determinations. Staying ahead of regulatory developments is critical, as rules frequently adapt to new scientific findings and market trends, impacting product formulations and go-to-market strategies.
The rapid evolution of this sector demands proactive strategies to ensure compliance while fostering innovation. Effective solutions focus on leveraging the latest scientific insights to address safety concerns, meet regulatory standards, and support the growth of dietary supplements and functional foods in a competitive market.
COSMETICS & PERSONAL CARE
Navigating the regulatory environment of the cosmetics and personal care industry requires deep technical understanding and meticulous attention to detail. Burdock Group provides safety and regulatory review services to help ensure product compliance with U.S. and international standards.
Our services cover a full range of needs, including safety assessments for ingredients and finished products, substantiation of product claims, and label reviews for regulatory compliance. We assist clients in aligning with FDA, EU, and other global regulatory frameworks, helping to mitigate risk and support successful market entry.
With evolving regulations and increasing scrutiny on product safety, manufacturers and marketers rely on expert guidance to keep their formulations compliant and their claims defensible. Burdock Group’s scientific and regulatory experts stay current with industry developments and work closely with clients to deliver practical, science-based solutions.
Whether launching a new product or reassessing an existing one, we support brands at every stage of development to ensure consumer safety and regulatory confidence.
EPA
Developing and marketing sanitizers and disinfectants in the U.S. requires strict adherence to Environmental Protection Agency (EPA) regulations, particularly under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Burdock Group provides scientific and regulatory support to help companies meet these requirements efficiently and effectively.
Our services include:
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FIFRA Registration Support – Guidance through the EPA registration process, including preparation of dossiers, data gap analyses, and coordination of required studies.
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Ingredient and Formulation Review – Evaluation of active and inert ingredients for regulatory acceptability and toxicological safety.
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Antimicrobial Claim Substantiation – Assistance in developing and substantiating antimicrobial claims, ensuring they align with EPA-approved language and avoid enforcement risks.
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Label Compliance Review – Review and development of compliant product labels in accordance with EPA and state-level regulations.
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Safety and Risk Assessment – Toxicological evaluation of product formulations and exposure scenarios to support risk-based decision-making.
With regulatory scrutiny increasing and the demand for effective hygiene products remaining high, navigating EPA and FIFRA requirements is critical. Burdock Group offers technical expertise and regulatory insight to support timely product approvals and ongoing compliance.