At Burdock Group, we have submitted more successful GRAS notifications than any other company or individual, with the highest success rate in the industry.

Our team’s expertise, attention to detail, and commitment to excellence ensure every submission meets the highest standards. From ingredient safety assessments to regulatory collaboration, we guide clients confidently through the GRAS process.

Choose Burdock Group for a proven partner that delivers results and ensures your ingredients are safe, compliant, and accepted in the marketplace.

A preliminary evaluation of available data is a critical first step in any project. It lays the groundwork for successful planning, decision-making, and execution. Key benefits include:

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• Defining Scope: Clarifies objectives, deliverables, risks, and constraints.

• Resource Planning: Ensures personnel, technology, and time are allocated effectively.

• Risk Identification: Highlights potential challenges early, allowing for mitigation strategies.

• Feasibility Assessment: Determines if the project is viable technically, financially, and operationally.

• Informed Decisions: Provides a solid foundation for adjusting scope, resources, or direction.

• Alignment: Keeps the project in line with organizational goals.

• Time & Cost Savings: Prevents costly rework and delays.

In short, preliminary evaluation ensures projects are well-defined, feasible, and aligned with strategic objectives, setting them up for success from the start.

At Burdock Group, we provide a clear pathway to U.S. regulatory compliance for your products. Our services are designed to guide you through complex requirements, ensuring your product meets all necessary standards.

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What Sets Us Apart:

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• Tailored Solutions: Customized guidance for your product and industry.

• Regulatory Expertise: Up-to-date knowledge of U.S. regulations and best practices.

• Compliance Assessments: Identify gaps and actionable steps to achieve compliance.

• Strategic Guidance: Advice on navigating challenges and optimizing your compliance journey.

• Education & Training: Equip your team with regulatory knowledge.

• Proactive Problem-Solving: Anticipate challenges and implement solutions early.

• Continuous Support: Ongoing guidance to maintain compliance as regulations evolve.

Whether entering the U.S. market, launching new products, or enhancing existing compliance, Burdock Group provides the expertise and support to ensure regulatory success.

At Burdock Group, we provide expert guidance on the strategic submission of food additive and color authorizations. Our team combines deep regulatory knowledge with practical experience to ensure your submissions are thorough, timely, and compliant.

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What Sets Us Apart:

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• Regulatory Insight: Stay up to date with the latest regulations.

• Strategic Timing: Optimize submission timing for regulatory and market advantage.

• Comprehensive Analysis: Evaluate safety data, usage levels, and consumer exposure.

• Customized Solutions: Tailored guidance for each product and its goals.

• Compliance Assurance: Prepare documentation that meets regulatory standards.

• Agency Communication: Facilitate clear, accurate interactions with regulatory authorities.

• Timely Updates & Risk Mitigation: Keep you informed and minimize potential delays.

Partner with Burdock Group to navigate complex regulatory processes confidently, ensuring your products meet the standards for successful authorization.

At Burdock Group, evaluating substances for approval is at the heart of our work. We conduct thorough hazard assessments to ensure safety, compliance, and regulatory approval.

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Our holistic approach combines toxicology, safety data, and regulatory expertise to deliver precise, actionable evaluations. By focusing on hazard determination and adherence to regulations, we help clients bring products to market confidently and safely.

At Burdock Group, our foundation is built on collaboration and advocacy. We prioritize your best interests, guiding you through every step of the regulatory compliance journey.

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By combining client-focused support, regulatory expertise, and proactive guidance, we ensure your goals are met efficiently and confidently. Our success is tied to yours, fostering trust, transparency, and shared success every step of the way.

A USDA survey-based consumption analysis assesses the dietary habits of the U.S. population to inform nutrition policy, public health, and industry decisions.

Key elements include:

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• Survey Design & Sampling: Collecting data from a representative cross-section of the population.

• Data Collection: Using 24-hour recalls, food diaries, and questionnaires to track foods and beverages consumed.

• Nutrient & Food Group Analysis: Evaluating nutritional content and categorizing foods to identify consumption patterns.

• Demographic & Trend Insights: Understanding differences across age, gender, income, and regions, and tracking changes over time.

• Policy & Research Applications: Supporting evidence-based nutrition policies, programs, and industry planning.

This analysis provides critical insights into U.S. dietary behaviors for informed decision-making.

Dietary intake assessments evaluate an individual’s or population’s nutritional intake to understand dietary patterns, identify nutrient deficiencies or excesses, and guide public health policies.

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Common Methods:

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• Dietary Recalls: 24-hour or multiple-day recalls of all foods and beverages consumed.

• Food Records/Diaries: Detailed logs of intake over a set period.

• Food Frequency Questionnaires (FFQ): Track frequency and portion of foods over time.

• Weighed/Estimated Records: Quantitative measurement of consumed foods.

• Biomarkers: Blood or urine tests to assess nutrient status.

• Direct Observation: Real-time recording of intake by trained observers.

• Technology-Assisted Tools: Apps, wearables, or online platforms for tracking intake.

• Nutrient Analysis Software: Estimates nutrient intake using food composition databases.

Using validated or combined methods improves accuracy and reliability. These assessments support clinical nutrition, research, public health, and personalized guidance.

Burdock Group provides end-to-end support for preclinical trials, ensuring regulatory compliance and scientific rigor from start to finish.

Our Services Include:

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• Trial Design: Structure studies to meet safety and efficacy requirements.

• Regulatory Compliance: Align with applicable standards for credible outcomes.

• Study Management: Monitor progress and ensure high-quality data collection.

• Data Analysis & Summarization: Turn results into meaningful insights.

• Manuscript & Publication Support: Prepare findings for scientific publication.

We offer a comprehensive, science-driven approach to preclinical research, supporting both successful studies and effective communication of results.

Burdock Group provides accessible, expert, and practical support to ensure your products meet EPA regulations confidently.

Key Strengths:

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• Accessible Expertise: Open communication and responsive support.

• Deep Knowledge: Up-to-date understanding of EPA requirements.

• Practical Solutions: Compliance strategies that work in real-world operations.

• Safety Assurance: Guidance to meet regulations and maintain high safety standards.

• Tailored Approach: Customized solutions for your products and business needs.

• Proactive Support: Identify and address potential issues early.

With Burdock Group, you gain a trusted partner, ensuring regulatory compliance and instilling confidence in your products and customers.

Study management at Burdock Group involves planning, executing, and overseeing studies that assess the environmental and human health impacts of substances, products, or rgegulated activities regulated by the FDA, USDA, and EPA.

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Key Elements:

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• Study Planning & Protocols: Define objectives, design methods, and align with regulatory uidelines.

• Regulatory Compliance: Ensure adherence to EPA rules and Good Laboratory Practices (GLP).

• Contracting & Oversight: Manage labs, budgets, timelines, and quality assurance.

• Data Collection & Analysis: Gather and analyze reliable, accurate data.

• Interpretation & Reporting: Translate results for regulatory decisions and prepare submission-ready documentation.

• Communication & Stakeholder Engagement: Maintain transparency with the regulators and other stakeholders.

• Adaptation & Follow-Up: Adjust protocols as needed and implement actions based on findings.

Effective study management ensures scientific integrity, regulatory compliance, and evidence-based protection of human health and the environment.

With over 30 years of experience, Burdock Group is a trusted partner in achieving safety and regulatory goals.

Our multidisciplinary team of toxicologists, scientists, and project managers offers deep expertise in food contact surface sanitizers, disinfectants, and EPA compliance, ensuring safe, compliant products and efficient project management.

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Key Points:

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• Extensive industry experience and regulatory knowledge

• Multidisciplinary team for comprehensive support

• Focus on product safety and compliance

• Expert guidance on EPA regulations and submissions

Under DSHEA, manufacturers must submit a New Dietary Ingredient Notification (NDIN) to the FDA at least 75 days before marketing a new ingredient.

This ensures the ingredient is reasonably expected to be safe for consumption.

Burdock Group helps by:

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• Facilitating safety studies and evaluations

• Compiling scientific data and toxicology assessments

• Preparing the NDIN submission to ensure regulatory compliance

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We provide the scientific and regulatory expertise needed to bring new dietary ingredients to market safely and efficiently.

Burdock Group has produced thousands of writings and publications to demonstrate the safety, efficacy, and compliance of products, supporting successful market entry.

Our Approach:

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• Provide robust scientific evidence for product substantiation

• Ensure regulatory compliance and alignment with industry standards

• Leverage extensive expertise and published research to validate findings

• Facilitate market access with credible, evidence-based documentation

Our work combines scientific rigor with practical guidance, making products ready for the market with confidence.

Burdock Group produces in-depth white papers and monographs on FDA and EPA regulations, offering expert analysis, research findings, and practical guidance.

White Papers Cover:

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• FDA compliance, inspections, and product approvals

• EPA enforcement policies, risk assessment, and chemical regulation

• Food safety, pharmaceutical oversight, and environmental risk communication

Monographs Cover:

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• FDA guidance on drugs, biosimilars, medical devices, and dietary supplements

• EPA policies on air and water quality, pesticides, and chemical risk management

These resources provide valuable insights into regulatory frameworks, policy developments, and best practices for industry professionals, stakeholders, and policymakers.

Burdock Group provides expert guidance on submissions for a wide range of FDA-regulated products and facilities, including food, dietary supplements, pharmaceuticals, and medical devices. Our proven track record of successful FDA acceptance demonstrates our deep expertise, broad industry coverage, and ability to navigate complex regulatory requirements efficiently.

Burdock Group provides end-to-end support for evaluating Food Contact Substances, ensuring safety, regulatory compliance, and environmental responsibility.

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Our services include:

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• Comprehensive Safety Assessment: Evaluate toxicology, chemistry, microbiology, and environmental effects to ensure safe use.

• FCN Preparation & Submission: Compile and submit Food Contact Notifications (FCN) under 21 U.S.C. 348(h)(1).

• Regulatory Compliance: Ensure submissions meet FDA requirements and demonstrate product safety for intended use.

• Environmental Review: Assess environmental impact and ensure compliance with NEPA standards.

• Expert Guidance: Provide clients with expert support throughout the evaluation and submission process.

Burdock Group offers a holistic, science-driven approach to FCS evaluation, helping companies secure regulatory approval while maintaining safety and environmental integrity.

Burdock Group helps ensure the scientific evidence behind your ingredient supports your claims. We analyze existing data, identify gaps, and prepare submissions for regulatory bodies like the FDA or EFSA.

Key services include:

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• Scientific Analysis: Review and assess research to ensure claims are supported.

• Claim Substantiation: Verify that evidence backs your ingredient’s health or functional benefits.

• Health Claim Guidance: Assist with health and qualified health claims, ensuring regulatory requirements are met.

• Data Gap Resolution: Identify and address missing information to strengthen your claim.

• Regulatory Submission Prep: Format and compile documentation for regulatory approval.

• Client Support: Guide you through the regulatory process and provide expert advice throughout.

Burdock Group provides a complete, science-based approach to substantiating claims, ensuring compliance and increasing the likelihood of regulatory acceptance.

Burdock Group provides expert testimony and litigation support for cases involving FDA regulations, offering specialized knowledge to assist legal proceedings.

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• Identify Regulatory Issues: Focus on FDA compliance, approvals, labeling, safety, or other regulatory matters central to the case.

• Qualified Experts: Collaborate with toxicologists, pharmacologists, regulatory specialists, and other FDA experts.

• Expert Witness Preparation: Ensure experts are qualified, prepare reports, and provide clear, credible testimony.

• Case Strategy Support: Analyze the case, assess strengths and weaknesses, and guide legal strategy.

• Regulatory Review: Examine FDA documents, submissions, inspection reports, and compliance history.

• Educate Legal Teams: Train attorneys and paralegals on FDA rules and regulatory nuances.

• Regulatory Guidance: Advise on strategies and options aligned with FDA standards.

Burdock Group helps legal teams navigate complex FDA issues with credible expertise, supporting strong, informed litigation strategies.

Burdock Group includes labeling as a key part of our consulting services, recognizing its critical role in clarity, compliance, and risk management.

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• Risk Reduction: Clear, accurate labeling helps minimize regulatory and safety risks.

• Effective Communication: Labels convey essential product information to consumers, professionals, and regulators.

• Regulatory Compliance: We ensure labeling meets all relevant standards and guidelines.

• Claim Support: Proper labeling validates product claims, including health, safety, or functional benefits.

• Customized Guidance: Solutions are tailored to each product and regulatory environment.

• Integrated Approach: Labeling is handled as part of a broader strategy for compliance and risk management.

Burdock Group provides a holistic, expert approach to labeling, helping products communicate accurately and comply confidently.

Registering a sanitizer or disinfectant with the EPA ensures the product is effective, safe, and environmentally compliant. Our firm guides clients through the process, which includes:

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• Product Classification: Determine if the product is a sanitizer, disinfectant, or other antimicrobial. Each type has different requirements.

• Active Ingredient Review: Check that the active ingredient is on the EPA’s approved list or submit new ingredients for review.

• Data Collection: Compile efficacy and safety data for the product, including environmental impact.

• Formulation Details: Specify the product’s formulation and active ingredient concentration for EPA evaluation.

• Submission to EPA: Submit a detailed application to the EPA’s Antimicrobial Division.

• EPA Review: The EPA evaluates the product’s effectiveness, user safety, and environmental impact.

• Registration Approval: If approved, the product can be legally sold and marketed.

• Labeling Compliance: Ensure labels reflect approved claims, usage instructions, and safety information.

• Ongoing Compliance: Maintain adherence to EPA rules, reporting, and updates as regulations change.

This process ensures your sanitizer or disinfectant meets regulatory standards and is safe and effective for consumers.

510(k) vs. PMA – FDA Medical Device Pathways

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• 510(k) Premarket Notification:

  • Used for devices that are similar to existing, legally marketed devices.

  • The manufacturer shows the device is substantially equivalent (SE) to a predicate device.

  • FDA reviews the submission, and if equivalent, the device can go to market.

• Premarket Approval (PMA):

  • Used for higher-risk or novel devices that are not substantially equivalent to existing devices.

  • Requires extensive scientific and clinical evidence, often including clinical trials.

  • FDA performs a thorough review and approves only if there is reasonable assurance of safety and effectiveness.

510(k) is a faster pathway for devices similar to existing ones, while PMA is a more rigorous review for higher-risk or new devices. Choosing the right pathway is crucial for market access and regulatory approval.

The FSMA, enacted in 2011, modernizes the U.S. food safety system by shifting from reactive responses to proactive prevention.

Key Points:

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• Preventive Controls: Food facilities must identify and address potential hazards before contamination occurs.

• Inspection & Compliance: The FDA can conduct more inspections and take swift action when issues arise.

• Imported Food Safety: Importers must ensure foreign suppliers meet U.S. safety standards.

• Contamination Response: The FDA can order recalls and take action to remove unsafe products.

• Collaboration: Encourages partnerships among agencies, industry, and international stakeholders.

• Produce Safety: Sets science-based standards for growing and harvesting fruits and vegetables.

• Third-Party Certification: Voluntary program for accrediting auditors to certify foreign food facilities.

• Records Access: The FDA can access records to trace contamination sources quickly.

FSMA focuses on prevention, risk-based strategies, and collaboration to protect public health and improve the safety of U.S. and imported foods.

The PMTA is an FDA-required submission for new or significantly modified tobacco products before they can be marketed. Our services help companies navigate this complex process:

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• PMTA Preparation: Compile scientific data, research, and documentation to show the product protects public health.

• Regulatory Compliance: Ensure the submission meets all FDA requirements and guidelines.

• Scientific Expertise: Provide support with toxicology, behavioral research, and other studies relevant to the product.

• Submission to FDA: Prepare and submit the application electronically according to FDA timelines.

• Regulatory Communication: Assist with responding to FDA questions and requests for additional information.

• Post-Submission Support: Guide companies through the review process and any follow-up requirements.

• Product Lifecycle Management: Support ongoing compliance, including updates or modifications to the PMTA as needed.

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These services combine industry knowledge and regulatory expertise to help tobacco companies navigate the PMTA process successfully.