About Us

We are a US-based consultancy, headquartered near Washington, DC. We provide expert
strategic and technical regulatory guidance to clients facing the complexities of advancing
potential new therapies from the bench to patients. With an in-depth understanding of the
evolving regulatory landscape, we specialize in helping organizations navigate the multifaceted
challenges that arise with the development of life-changing therapies.

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Strategic and technical solutions to navigate regulatory challenges

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​In today’s landscape, innovators must address a growing array of regulatory requirements
across diverse jurisdictions. Our team of experienced professionals offers a unique combination
of technical expertise and strategic insight, helping clients not only satisfy compliance standards
but also optimize development pathways in the global regulatory environment. We work closely
with innovators to identify potential regulatory hurdles early, develop tailored strategies to
mitigate risks, and ensure that global development plans are fully aligned with local market demands.

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Forging optimal regulatory pathways

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​Whether you are developing a novel entity, amending an existing product, or bringing forward a
more affordable therapeutic version, Austin Bio provides the guidance you need to turn potential
regulatory challenges into opportunities. We merge creative regulatory strategy with scientific
expertise to help you navigate the regulatory pathway from the bench to the patients.