Regulatory And Commercialization Expertise Resources
Regulatory and preclinical consulting are the first of several member support services ARMI plans to provide to its members as part of the BioFabUSA program. The membership of BioFabUSA is diverse in expertise, interests, and business plans. These regulatory and preclinical consulting services seek to support this diverse group as part of the larger mission of seeking to support existing industries and grow new ones.
BioFabConsulting will be headed by Richard McFarland PhD MD (Chief Regulatory Officer) and Becky Robinson-Zeigler PhD (Deputy Chief Regulatory Officer). Together, Drs. McFarland and Robinson-Zeigler have a roughly a quarter century of domestic and international experience across the spectrum of review, policy, jurisdiction, and types of medical products (biologics, devices, drugs, and combination products) relevant to tissue engineering and regenerative medicine applications.
To initiate a BioFabConsulting engagement, please e-mail RACER@armiusa.org. Upon contact, you will receive an e-mail to set up an initial, confidential consultation. These initial, confidential consultations will be free of charge to ARMI | BioFabUSA members. To help ensure the most productive initial, confidential consultation the client is encouraged to provide BioFabConsulting with a “pre-read” document at least one week before the discussion is scheduled to occur. After the discussion, BioFabConsulting will propose an approach to addressing the overall consultation needs expressed by the client, and provide a proposed scope of work and an estimated budget (where appropriate), including applicable hourly rates.