In-house Regulatory and Commercialization Expertise

Individualized confidential consulting is one of the support services ARMI provides to its members as part of the BioFabUSA program. The membership is diverse in terms of areas of expertise, strategic interests and tactical goals. BioFabConsulting meets members where they are and provides strategic advice to help them achieve their specific goals. This can include engagement of our in-house experts on regulatory areas, as well as commercialization and technical issues. Specifically within regulatory, this can range from overall strategy to specific support on any regulatory area, including creation and submission of FDA applications. These client-specific efforts contribute to the larger mission of supporting existing industries and growing new ones.

Standardization Efforts

Standardized methods for characterization of regenerative medicine products, standardized information on source and ancillary materials and standardized assays for sterility testing are a few examples of areas in which standards can assist firms in developing regenerative medicine products that can meet regulatory expectations.


Getting a product out of the lab and into the hands of doctors who can transform and even save people’s lives is a complex challenge. BioFabConsulting can help you get it all done.

BioFabUSA, a program of ARMI, is a public-private partnership with more than 170 members, including companies, academic institutions and not-for profit organizations.




Learn more about work underway to build the biofabrication ecosystem and accelerate the science of regenerative medicine.