EXPERT REGULATORY SERVICES

Ensuring Compliance for Market Success

STRATEGIES TO MARKET ENTRY

Pathway to Market Analysis:

Entering a new market involves more than just product development—it requires a thorough understanding of the regulatory landscape, consumer expectations, and competitive positioning. KGK Science offers comprehensive pathway-to-market analysis, providing you with key insights into the regulations and industry standards specific to your target market. We assess market dynamics, competitor activity, and regulatory trends to create a tailored strategy that maximizes your product’s potential for success. By evaluating the entire market ecosystem, we ensure your product is positioned for compliance and commercial success from the outset.

Gap Assessment

To successfully launch a product, identifying and addressing regulatory compliance gaps is critical. KGK Science conducts thorough gap assessments, examining your existing data, formulations, and marketing claims to pinpoint any areas that may fall short of regulatory standards. We provide a detailed roadmap highlighting the necessary steps to bridge these gaps, ensuring that your product adheres to all safety, labeling, and compliance requirements. Our proactive approach helps mitigate risks and accelerates the approval process, allowing you to move forward with confidence and meet your launch timelines.

SAFETY DOSSIERS

NDI Notifications:

Dietary ingredients used in supplements can be classified as either Old Dietary Ingredients (ODIs) or New Dietary Ingredients (NDIs), depending on whether they were marketed and sold in interstate commerce before October 15, 1994. Our regulatory experts will determine the status of your dietary ingredient, whether old or new, and provide a customized, all-in-one solution to meet NDI compliance. NDI requirements are highly detailed, necessitating expertise in both identity (chemistry) and safety (toxicology). Led by a co-author of the FDA’s NDI draft guidance and a former FDA Branch Chief for Dietary Supplement Regulation Implementation, our team will assist you throughout the entire NDI submission process. Our services include strategy development for filing an NDI notification, technical review of identity specifications, GAP analysis of toxicology data, recommendations for pre-clinical safety studies and their conduct, and direct correspondence with the FDA, including facilitation of a Pre-Notification meeting. KGK Science prepares and submits comprehensive NDI notifications, organizing all necessary safety and scientific data, ensuring your submission is complete, accurate, and positioned for regulatory approval.

GRAS Conclusions:

Achieving Generally Recognized as Safe (GRAS) status for your ingredients is essential for regulatory compliance and consumer confidence. The Federal Food, Drug, and Cosmetic Act imposes strict safety regulations on food ingredients, and internet-savvy consumers increasingly seek FDA awareness and approval. KGK Science specializes in preparing and submitting GRAS conclusions, providing the scientific evidence needed to support the safety of your ingredients. Our experts, qualified by scientific training and experience, will draft your GRAS conclusion, which can be independently reviewed (self-GRAS), reviewed and submitted to the FDA (FDA GRAS notice), or formally petitioned to the FDA (food additive petition). Our all-in-one customized solution includes technical review and GAP analysis, planning and conducting studies to support identity and safety data, in-house expertise in statistics and food toxicology, and assembling data into a comprehensive dossier. Additionally, a panel of independent expert food scientists will review the GRAS conclusion and provide final sign-off letters, ensuring your submission is thorough, compelling, and positioned for regulatory acceptance.

CANADIAN SERVICES

Product Licensing Applications (PLAs)

Bringing a new product to the Canadian market requires obtaining the necessary licenses and approvals from Health Canada, specifically through the Natural and Non-Prescription Health Products Directorate (NNHPD). This regulatory body ensures that Canadians have access to safe, effective, and high-quality natural health products. Securing product licensing through the NNHPD not only meets the legal requirements for selling in Canada but also maximizes the value of efficacy claims in your product marketing. KGK Science’s Canada-based regulatory team, led by an experienced Federal Regulator, will support your business in securing the evidence and assessments needed for product licensing. Our expert services include a technical review of quality specifications, safety and efficacy evidence, and a summary of claims supported by regulatory requirements. We also handle the completion and submission of the Product License Application (PLA), ensuring all documentation meets Health Canada’s stringent standards and facilitating a seamless approval process to help you launch your products with confidence.

New Substances Notification (NSN)

In Canada, Natural Health Products (NHPs) are regulated by Health Canada under the Natural Health Products Regulations, which ensure that these products are safe, effective, and of high quality. When introducing a new substance as part of an NHP, manufacturers may need to submit a New Substances Notification (NSN) if the substance has not been previously approved for use in NHPs. KGK Science offers specialized support for companies navigating this regulatory process, ensuring compliance with Health Canada’s requirements for new ingredients.

Ingredient Masterfiles

Ingredient Master Files are essential for ensuring transparency and regulatory compliance. KGK Science creates and maintains comprehensive Ingredient Master Files, detailing the composition, safety, and manufacturing process of your ingredients. These files are a valuable resource for regulatory submissions and for providing detailed information to regulatory authorities, ensuring that your ingredients meet the highest standards at the same time protecting your intellectual property.

REGULATORY LETTERS

GRAS Feasibility Assessment:

Determining whether an ingredient can achieve GRAS status is a key consideration in product development. KGK Science provides GRAS feasibility letters, offering a preliminary assessment of the ingredient’s safety and regulatory prospects. This service helps guide your development process, providing an early indication of whether an ingredient is likely to be considered GRAS by regulatory authorities.

Evidence for Old Dietary Ingredient Status

For products containing Old Dietary Ingredients (ODIs) used in dietary supplements prior to the Dietary Supplement Health and Education Act (DSHEA) of 1994, KGK Science provides comprehensive support to maintain regulatory compliance. These ingredients require documentation to verify their status and be exempt from the submission of a New Dietary Ingredient (NDI) notification to the FDA. Our regulatory operations experts conduct thorough investigations, utilizing a robust library of pre-DSHEA dietary ingredients and independent, verifiable evidence, such as product labels and ingredient supply catalog entries. We provide Letters of Support that document the historical use and safety of these ingredients, ensuring your ODI-based products can continue to be marketed without interruption. These letters are a cost-effective and efficient way to validate ingredient safety based on historical use and minimize regulatory risk.

Regulatory Status Review

Understanding how the FDA views a proposed ingredient is critical before launching a new product. At KGK Science, we offer a detailed Regulatory Status Review to assess the FDA’s perspective on your ingredient. Our regulatory experts analyze the ingredient’s intended use, composition, and supporting data to determine whether it qualifies as a dietary supplement, food additive, or requires other regulatory classifications. We provide clear recommendations on the appropriate regulatory pathway, including whether the ingredient requires a New Dietary Ingredient (NDI) notification, a GRAS designation, or another form of approval. This review ensures that you enter the market with a thorough understanding of your regulatory obligations, helping you avoid compliance issues and potential enforcement actions

Review of Processing to Support “No Chemical Alteration”

Maintaining the natural integrity of dietary ingredients is critical to meeting regulatory standards for “no chemical alteration.” KGK Science offers expert reviews of ingredient processing methods to ensure compliance with FDA guidelines. Our team conducts a thorough analysis of extraction, purification, and manufacturing processes to confirm that no chemical alteration has occurred, preserving the ingredient’s natural state. If modifications are needed, we provide recommendations to adjust processes while maintaining product quality and meeting regulatory requirements. This review offers clients peace of mind, ensuring that their ingredients are processed in accordance with FDA expectations and can be marketed without regulatory complications.

STRATEGIC REGULATORY CONSULTING SERVICES

Toxicology Reviews and Risk Assessment

Toxicology Reviews are critical for determining the safety of new ingredients or products. KGK Science offers thorough toxicological assessments to identify any potential safety concerns related to ingredients in dietary supplements, foods, and pharmaceuticals. Our experts review existing toxicology data, conduct literature searches, and recommend additional studies if necessary. These reviews ensure that your product complies with regulatory safety standards, minimizes risks to consumers, and meets the expectations of agencies like the FDA and EFSA. We deliver comprehensive reports that provide clear conclusions on safety, enabling you to proceed with confidence in your product’s development.

Market Entry

Entering new markets can be a complex process, and KGK Science offers expert guidance to streamline market entry for your products. We assess the regulatory requirements for launching dietary supplements, conventional foods, and nutraceuticals into the US and Canadian markets. Our team provides clear recommendations on necessary registrations, approvals, and documentation, ensuring that your product meets local regulations and standards. Whether you’re expanding into a new region or launching an innovative product, our market entry services help you navigate the regulatory landscape and reduce time-to-market.

Structure Function Claim Substantiation Files for FTC Compliance

Structure function claims, which describe the role of a nutrient or dietary ingredient in supporting normal body functions, must be substantiated to comply with FTC regulations. At KGK Science, we create comprehensive claim substantiation files that provide scientific evidence supporting the accuracy and truthfulness of your product claims. Our experts conduct a detailed review of clinical studies, peer-reviewed research, and other supporting data to ensure that your claims are backed by credible evidence. This process helps protect your brand from regulatory scrutiny and ensures that your marketing materials are compliant with FTC regulations.

30-Day Structure Function Notice e-Portal Submissions for FDA Compliance

When making structure function claims, companies must notify the FDA within 30 days of first marketing the product. KGK Science provides efficient 30-Day Structure Function Notice submissions through the FDA’s e-Portal. Our team ensures that your submissions are accurate, complete, and comply with FDA regulations. We prepare the necessary documentation and handle the submission process, allowing you to meet regulatory deadlines while maintaining focus on your product launch. This service helps you avoid potential enforcement actions related to structure function claims, ensuring timely and compliant product marketing.

Evaluation of Labels and Labeling (e.g., marketing materials, social media) for Disease Claims

Regulatory agencies such as the FDA and FTC closely scrutinize labels and marketing materials for disease claims, which are prohibited for dietary supplements unless approved by the FDA. KGK Science provides expert evaluation of labels, marketing materials, and social media content to ensure that your product’s claims are compliant with regulatory guidelines. Our team reviews your materials to identify any potential disease claims and advises on revisions to ensure compliance. This service helps protect your brand from regulatory enforcement actions and ensures that your marketing is both effective and compliant.

Creation of SOPs (e.g., cGMPs, Adverse Event Reporting)

Standard Operating Procedures (SOPs) are critical for maintaining compliance with regulatory requirements, including current Good Manufacturing Practices (cGMPs) and Adverse Event Reporting. KGK Science assists in the creation and implementation of SOPs tailored to your company’s operations. Our experts develop clear, actionable procedures that ensure your facility meets regulatory standards, supports product quality, and complies with FDA and Health Canada requirements. Whether you need SOPs for manufacturing, quality control, or reporting adverse events, our services provide the foundation for a compliant and efficient operation.

Label Reviews for Misbranding

Misbranding occurs when product labels fail to meet regulatory standards, which can lead to costly enforcement actions. KGK Science offers comprehensive label reviews to ensure that your product labels are accurate, clear, and compliant with FDA and FTC regulations. Our team examines your labels for compliance with ingredient listings, claims, and formatting requirements, helping you avoid misbranding issues. This review process minimizes the risk of regulatory actions and ensures that your labels meet the standards required for successful product marketing.

CMO Agreement Consulting

Contract Manufacturing Organization (CMO) agreements are a critical aspect of ensuring the quality and compliance of outsourced manufacturing. KGK Science provides expert consulting services to help you navigate CMO agreements, ensuring that your manufacturing partners meet regulatory standards and your product’s quality requirements. Our team reviews and advises on the terms of CMO agreements, including quality control processes, cGMP compliance, and product specifications. This service helps ensure that your products are manufactured to the highest standards, protecting your brand and maintaining compliance with FDA regulations.

Supply Chain Management and CMO Support

Effective supply chain management is crucial for maintaining product quality and regulatory compliance. KGK Science offers comprehensive support for managing your supply chain, including oversight of Contract Manufacturing Organizations (CMOs). Our experts assess and monitor your supply chain processes to ensure that raw materials, manufacturing practices, and finished products meet regulatory requirements. We provide guidance on cGMP compliance, quality control, and documentation, helping you maintain a reliable and compliant supply chain. This service reduces the risk of supply chain disruptions and ensures that your products meet the highest standards of quality and safety.

CITIZEN PETITIONS

Exemption from 100% Identity Testing

Under FDA regulations, manufacturers are typically required to conduct 100% identity testing for dietary ingredients in finished products to ensure that they match the listed ingredients. However, exemptions can be sought through Citizen Petitions when identity testing for every batch is impractical or unnecessary due to the consistency of the ingredient’s supply chain or the reliability of alternative testing methods. KGK Science assists in preparing well-documented petitions that justify exemptions from 100% identity testing. Our team compiles the necessary evidence, including supplier verification, Certificate of Analysis (COA) data, and alternate testing protocols, to demonstrate compliance with FDA’s quality control requirements without the need for 100% testing.

Dietary Fiber Status

The FDA has strict criteria for what qualifies as dietary fiber on nutrition labels, and certain fibers may require a Citizen Petition to obtain or clarify their status. KGK Science provides support in submitting petitions to request FDA recognition of specific non-digestible carbohydrates as dietary fibers, based on scientific evidence of their health benefits. Our regulatory experts gather and present clinical data, safety reviews, and relevant research demonstrating the fiber’s physiological benefits. This service helps companies ensure their products are labeled correctly and compliant with FDA regulations, avoiding misbranding risks.

Qualified Health Claims/Health Claims

Qualified Health Claims and Health Claims allow companies to communicate the relationship between a nutrient or ingredient and health outcomes. However, these claims must be substantiated with strong scientific evidence and, in some cases, require FDA approval through a Citizen Petition. KGK Science assists clients in preparing Citizen Petitions to request approval for health claims, providing comprehensive scientific documentation to support the proposed claim. Our team conducts in-depth reviews of clinical studies and research to substantiate the claim, whether it’s a Qualified Health Claim with disclaimers or a fully authorized Health Claim. We guide you through the petition process, ensuring that your claim is backed by credible evidence and meets FDA’s stringent requirements.

COSMETIC SERVICES (US FDA)

Safety Substantiation:

Under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, cosmetic companies are now required to substantiate the safety of their products before marketing. KGK Science offers comprehensive Safety Substantiation services to ensure your products meet FDA requirements. Our expert team assists with:

Comprehensive Safety Assessments: Conducting thorough safety evaluations of cosmetic ingredients and finished products.
Scientific Data Compilation: Gathering and analyzing scientific studies and data to demonstrate product safety.
Safety Documentation Preparation: Preparing substantiation documentation that aligns with FDA's stringent safety requirements.
Gap Analysis: Reviewing existing safety data and identifying any gaps that may require further testing.
Testing Protocol Development: Designing and overseeing testing protocols for new ingredients or product formulations.
Label and Claims Review: Ensuring that product labels and claims are compliant with safety and regulatory standards.

Cosmetic Ingredient/Product Registration:

The Modernization of Cosmetics Regulation Act (MoCRA) introduces new mandatory registration requirements for cosmetic facilities and products. KGK Science offers expert guidance and support through the entire Cosmetic Ingredient/Product Registration process, including:

FDA Facility Registration: Assisting with the registration of cosmetic manufacturing facilities.
Product Listing Submissions: Submitting detailed product listings, including ingredient information, to the FDA.
VCRP Participation Guidance: Advising on participation in the Voluntary Cosmetic Registration Program (VCRP) for added transparency.
Electronic Submission Assistance: Handling electronic submissions through FDA’s systems for timely and accurate compliance.
Registration Updates and Monitoring: Keeping your registrations and listings current with FDA regulations and monitoring for any necessary updates.
Recordkeeping Support: Advising on proper recordkeeping practices to ensure compliance for registered facilities.

PHARMACOVIGILANCE

Serious Adverse Event Reporting (Dietary Supplements and Cosmetics)

Post-market surveillance is essential for monitoring the safety of your products once they reach the market, particularly in the nutraceutical and cosmetic industries. KGK Science offers comprehensive Serious Adverse Event Reporting (SAER) services, ensuring compliance with regulatory requirements and protecting consumer safety. Managing SAER can be especially challenging for start-ups, as it requires significant investment in dedicated full-time staff. KGK Science serves as a one-stop shop for all your SAER needs, operating a high-quality Communications Center in London, Ontario, Canada. Our team handles the intake of all reported events from the U.S. and Canada, triaging product complaints and adverse events with the help of qualified healthcare practitioners to assess their severity.

Our SAER services include:

A Canada-based communication center to receive reports from both Canada and the U.S.
Triage services to assess the severity of reports and complaints.
Active pharmacovigilance monitoring of safety signals from product complaints.
Management of post-marketing safety reporting requirements to ensure compliance.
Proper handling and secure storage of patient-sensitive data.
Statistical analysis of reports for safety signals and risk assessment.
Reporting to FDA MedWatch to comply with U.S. FDA SAE reporting requirements.
A confidential database for data compilation and record keeping.
Follow-ups with patients as per regulatory requirements.
Reporting events and reactions to U.S. FDA, Health Canada, and other health authorities.
Quarterly reports on all events, including statistical analysis and assessment of the need for regulatory action.