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The Gene Therapy Experts...and more.

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. 

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

A niche consultancy for strategic and technical regulatory solutions to advance global health

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