Texin Global Consulting, LLC, established in 2005, is headquartered in Florida with an office in Massachusetts. We specialize in a comprehensive range of regulatory affairs consulting services across Pharmaceuticals, Biologics, and Cell/Gene Therapies. Our team of seasoned consultants brings extensive expertise in gene therapies, as well as small and large molecules.

With over 26 years of experience in both large multinational corporations and pharmaceutical startups in the U.S., we excel in Regulatory Affairs Strategy for Clinical, Nonclinical, and CMC processes. Our expertise also spans Compliance, Global GMP Requirements, and Quality Assurance, supporting drug products from early-phase development through post-marketing.

Texin Global Consulting provides robust support for GxP audits across manufacturing facilities, subcontractors, suppliers, warehouses, and distribution centers. Additionally, we collaborate with international companies to represent as a legal US FDA Agent and to facilitate business alliance programs, including Licensing In/Out opportunities on a global scale.