The dietary supplements industry is evolving fast—so are its regulations. We help brands navigate DSHEA, 21 CFR Part 111, labeling rules, and ingredient compliance with clarity and precision. Whether you’re launching a new product or managing a legacy line, we guide formulation review, claims strategy, and risk assessment. Our team ensures you’re audit-ready, market-aligned, and built for longevity.
We also assist with GRAS and NDI determinations, SOP development, and global expansion. With Skalli, you gain not just compliance, but confidence. Let’s make regulatory your competitive edge.
Botanical and herbal products require tailored regulatory strategies grounded in both science and tradition. We help ensure your products meet FDA standards while respecting their natural heritage. Our team supports labeling, substantiation, and ingredient reviews, including identity verification and safety documentation. We navigate DSHEA compliance, herbal monographs, and NDI considerations with precision.
Whether capsules, tinctures, or teas, we align your claims with market expectations. Our deep experience helps you avoid pitfalls while preserving brand integrity. Skalli is your trusted partner in herbal compliance.
Functional foods and nutraceuticals face complex regulatory hurdles due to their hybrid nature. We clarify whether your product is a food, supplement, or something else—and ensure it’s labeled and marketed correctly. Our experts help substantiate claims, determine ingredient compliance.
And align with FDA food labeling rules. We also support GRAS documentation, food additive status, and product classification for domestic and global markets. Whether you’re creating a probiotic snack or a fortified beverage, we bring strategy and structure. Skalli ensures your innovation is both marketable and compliant.
Sports nutrition brands operate in a highly competitive, highly regulated space. We help you stand out—safely and compliantly. Our consultants guide you through label reviews, banned substance screening, and performance claim substantiation. We ensure you’re meeting FDA, FTC.
And third-party standards while protecting your brand integrity. Whether it’s a pre-workout, recovery drink, or endurance product, we manage compliance from formulation through marketing. We also assist with GMP audits and product safety systems. With Skalli, your compliance is as strong as your product.
Private label products require regulatory systems that are fast, flexible, and fail-safe. We help brands vet manufacturers, verify product specs, and meet FDA compliance at every step. Our team supports SOP development, label audits, and contract manufacturer evaluations.
Whether launching your first SKU or scaling your line, we provide quality assurance systems that grow with your business. We help prevent supply chain gaps, non-compliance, and costly recalls. Skalli integrates seamlessly into your operations—acting as your regulatory eyes and ears.
Expanding into the U.S. market means aligning with FDA and FTC expectations. We help international companies translate their documentation, product claims, and marketing strategies for U.S. regulatory success. From ingredient and label reviews to import documentation and classification.
Our consultants simplify the process. We also provide risk assessments, substantiation support, and compliance training for your local team. Whether entering through e-commerce or distributors, we set you up for long-term success. Skalli helps you go global the right way.
Fast-growing wellness brands need fast, smart compliance strategies. We support startups with regulatory essentials like product classification, compliant labeling, digital marketing alignment, and supply chain vetting. Our team ensures your launch is backed by strong SOPs, risk assessments, and substantiated claims, quality checks, ongoing support, and scalability.
Whether you’re scaling an e-commerce brand or prepping for investment, we tailor our support to your growth stage. We also help you avoid common startup missteps. With Skalli, your compliance won’t just keep up—it will drive you forward.
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