leanRAQA

leanRAQA is a private U.S.-based regulatory affairs and quality assurance consulting company focused primarily on medical device and adjacent life science clients. The firm provides regulatory strategy, regulatory submissions support, quality systems and compliance services, audit management, due diligence, and technical support. Its client base appears to include emerging and small-to-mid-sized companies in medical devices, and in some descriptions also biotech, pharmaceuticals, biologics, dietary supplements, cosmetics, and food. Rather than developing its own therapeutic products, leanRAQA operates as a specialized services business helping clients navigate FDA and related compliance requirements and accelerate commercialization.