McKell Co. provides regulatory consulting for the personal care and OTC industry, guiding brands and manufacturers through U.S. FDA requirements and an evolving compliance landscape.

Founded by Susanne McKell, the firm is built on deep, hands-on industry experience across product development, sourcing, quality, and regulatory operations. This end-to-end perspective allows McKell Co. to deliver guidance that is not only compliant—but practical, efficient, and aligned with real-world business needs.

We support the full product lifecycle—from concept through commercialization—ensuring products are safe, properly labeled, and ready for market. Services include MoCRA readiness, FDA product and facility listings, labeling and claims compliance, and OTC Drug Facts support.

Our approach is commercially minded and solutions-driven. We translate complex regulations into clear, actionable direction so teams can move quickly while minimizing risk.

By operating as an extension of your team, McKell Co. helps navigate regulatory complexity, avoid costly missteps, and bring compliant, market-ready products to shelf with confidence.