Mandala International

Mandala International is a private healthcare-focused regulatory and market-access consulting company that helps manufacturers commercialize regulated health products in Latin America. The company provides product registration, regulatory strategy, gap analysis, license hosting, legal regulatory representation, post-registration surveillance, GMP/CRO audit preparation, laboratory support, and regulatory due diligence. Its service scope spans pharmaceuticals, medical devices, cosmetics, food supplements, sanitizing products, and some veterinary products, with particular emphasis on Brazil, Mexico, Colombia, and Peru. Rather than developing its own therapeutics, Mandala acts as an outsourced regulatory and operational partner for companies seeking entry into LATAM markets.