Austin Bio Consulting is a global, woman-owned, minority business entity founded in 2010.  We serve as a regulatory partner in pioneering the ethical development of life-changing therapies, increasing global access to quality-assured medicines, and forging pathways for products that address rare diseases. 

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We specialize in global regulatory strategy and CMC services for biologics, biosimilars, combination products, cell therapies, gene therapies, medical devices, and small molecule pharmaceuticals.