Simplify Your QMS with Template Packages

Navigating the complex regulatory environment for dietary supplements, including FDA 21 CFR Part 111 (cGMPs), requires meticulous attention to detail. Qualitas provides expert guidance for ingredient sourcing, manufacturing controls, labeling, claims substantiation, and facility registration, ensuring your products are safe, compliant, and market-ready.

From farm to fork, food safety and quality are paramount. Our services for the food industry cover critical areas such as FDA 21 CFR Part 117 (Preventive Controls for Human Food), HACCP, and GFSI-benchmarked schemes. We assist food brands and manufacturers with quality management system development, supplier audits, and regulatory reviews to protect public health and your brand's integrity.

The beverage sector faces its own distinct set of quality and compliance challenges, from raw material purity to processing controls and packaging integrity. Qualitas supports beverage brands and manufacturers in achieving compliance with relevant FDA regulations and industry best practices, ensuring product safety, consistency, and consumer satisfaction across all categories.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has significantly expanded FDA's authority over cosmetics. Qualitas offers comprehensive support for cosmetic and personal care brands and manufacturers, including ISO 22716 (Cosmetics GMP), label reviews, formula safety assessments, product listings, and claims substantiation, ensuring full compliance and successful market entry.

For Over-the-Counter (OTC) drugs and other diverse CPG categories, strict adherence to quality and regulatory standards is non-negotiable. Qualitas provides robust quality management and compliance services tailored to these sectors, assisting with everything from QMS development and audits to emergency support, helping you meet the highest benchmarks for product safety and regulatory assurance.