Regulatory & Quality Support Built Around Your Business

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Labels, Formulas, and Claims That Work Together

Your label and marketing should accurately describe your product and be supported by evidence. We help you identify where ingredients, claims, and market requirements need closer attention.

Discuss a product review

  • Label, Website & Marketing Review

    Review of product labels, ingredient declarations, Supplement Facts or Nutrition Facts panels, required statements, website content, advertising, and marketing claims.

  • Formulation Compliance & Claims Substantiation

    Assessment of ingredients, quantities, intended use, and supporting evidence. We consider whether the research matches your formula, dose, target customer, and proposed claims within the lens of FDA, FTC, Health Canada - and to a much deeper level than what AI can offer.

  • Canadian NHP Licensing

    Support with formula and evidence assessment, product licence applications, import licensing, permitted claims, label requirements, and responses to Health Canada questions.

  • U.S. Structure/Function Notifications

    Preparation of applicable FDA claim notifications using your final label and claim information.

  • Team Training

    Training tailored to your products and team responsibilities, including labels, claims, marketing, and product compliance.

Set Expectations Before Production and Follow Through Afterward

Choosing a manufacturer involves more than price, minimum order quantities, and lead time. We help you evaluate the partner and establish expectations for quality, testing, documentation, and communication.

Discuss your manufacturer needs

  • Manufacturer Search & Selection

    Helping you define your requirements, identifying potential manufacturers, and comparing their suitability for your product and business.

  • Manufacturer & Supplier Qualification

    Review of capabilities, credentials, quality procedures, testing practices, documentation, and how the partner handles changes and product issues.

  • Manufacturing Onboarding

    Support establishing specifications, testing expectations, quality responsibilities, documentation access, and escalation processes before production.

  • Remote & On-Site Audits

    Assessment of manufacturing and quality practices, with prioritized findings and recommended follow-up.

Quality Processes Your Team Can Put Into Practice

As your business adds products, partners, and people, quality decisions need clear owners, current records, and consistent follow-through. We help establish those processes and strengthen the systems you already use.

Discuss your quality needs

  • Quality Management Systems & SOPs

    Procedures, forms, and responsibilities tailored to your operations, including document control, training, supplier qualification, release, change control, investigations, and corrective actions.

  • Specifications & Testing Programs

    Support developing and reviewing product specifications, testing plans, certificates of analysis, and release documentation.

  • Shelf-Life & Stability Programs

    Study planning, laboratory coordination, protocol and data review, and support evaluating shelf life in the intended packaging.

  • Investigations, Complaints & Recall Readiness

    Support with nonconformances, out-of-specification results, corrective actions, complaint and adverse-event processes, recall procedures, and team training.

  • Ongoing Quality & Regulatory Leadership

    Remote support as an extension of your team, including verifying manufacturer practices, product reviews, investigations, training, and management. Fractional QA/RA leadership is available where that level of oversight fits your needs.

Prepare the Product and Documents For E-Commerce

A digital retailer request may involve more than the listing. Labels, stability, testing, manufacturer information, and product records need to be up to date and available.

Discuss a platform or retailer issue

  • Amazon, TikTok, FullScript & Retailer Support

    Review of compliance-related requests, product listings, claims, images, and supporting documentation.

  • Testing & Documentation Review

    Assessment of certificates of analysis, specifications, test results, and manufacturer or laboratory records.

  • Response Planning

    Identification of gaps and preparation of a comprehensive response that addresses the underlying issue hindering listing.

Platforms and retailers are constantly updating their requirements. Our work helps you prepare and respond to the changing times.

Not sure what your intended sales channel may require? Start with our free tool, Where Do You Plan to Sell?

Learn the Process Before Committing to Production

Product concept, claims, formula, manufacturer, testing, pricing, and sales channels all affect each other. Understanding how helps you decide what needs to happen next before you pay your deposit.

  • Supplement Startup Essential Training (SSET™)

    Our signature training provides a structured foundation for new founders, including how the industry operates, manufacturer selection, quality responsibilities, and the decisions involved in preparing to launch.

    Explore startup training

  • Tailored Startup Services

    For founders with a committed launch, we can provide focused support with product compliance, labels and claims, manufacturer qualification, and manufacturing onboarding.

  • Private Startup Consultation

    A confidential, one-hour session to help you make that specific decision, tailored to your specific situation. A great option for specific questions, rather than a replacement for the full training program found in SSET™.

    View startup consultation

How We Work

Tell us about your business, the issue, and your timing. We’ll discuss the appropriate scope, information needed, and fees before starting.

Some clients need a single touch-point. Others need a broader assessment, implementation support, or ongoing quality and regulatory leadership. We’ll shape the engagement around the work required.

Not sure where to start?

Tell us a little about your business and get acquainted in a meet & greet, discuss your needs, and explain how we can help.

Contact us