FDA & Global Regulatory Solutions for Health & Wellness Innovators
Founded to simplify regulatory complexity, The Skalli Group was built on the belief that compliance should empower—not hinder—innovation. With deep industry experience and a commitment to transparency, we guide health and wellness brands toward confident, compliant growth.
Ensure your products meet FDA and global regulatory standards with expert guidance on 21 CFR 111, GRAS, NDI, and label review.
Build robust QA/QC systems that align with current Good Manufacturing Practices. From batch records to CAPA, traceability, and training documentation.
Clear, compliant documentation that supports regulatory submissions and internal processes. We craft SOPs, and white papers with precision.
Prepare for FDA, NSF, or ISO audits with confidence and clarity. Our comprehensive mock audits and response strategies reduce risk.
Navigate regulations with scalable strategies tailored to your innovation. We create market entry plans and risk-based roadmaps.
Expand internationally with region-specific regulatory expertise. We support EFSA, NHP, LATAM, and protocols, and partner vetting.
We support brands with end-to-end regulatory solutions—from formulation reviews to 21 CFR 111 compliance—ensuring safe, and market-ready products.
Navigating the complexity of traditional and modern herbals, we help ensure proper classification, claim substantiation, and international regulatory alignment.
We empower startups with foundational compliance from labeling and claims to SOPs and risk assessments supporting fast & smart growth.
Our team helps bridge food and supplement regulations, supporting compliant innovation & market entry strategies across diverse jurisdictions.
Our consultants bring decades of FDA and global regulatory experience across dietary supplements, and nutraceuticals,.
We translate dense regulatory language into clear, actionable steps—so you stay informed, empowered.
Beyond compliance, we build scalable systems and roadmaps aligned with your innovation, growth, and global expansion.
Transparency, precision, and accountability are not just values—they’re how we do business, every day, with every client.
At The Skalli Group, our greatest measure of success is the satisfaction and trust of the companies we serve. From emerging wellness startups to established global brands, clients choose us for our deep regulatory expertise, personalized approach, and commitment to delivering clear, actionable solutions.
Our collaborative partnership helps clients confidently navigate complex FDA and international regulations—turning compliance challenges into growth opportunities. Hear directly from those who have experienced the Skalli difference.
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