Regulatory, and preclinical consulting are the first of several member support services ARMI plans to provide its members as part of its BioFabConsulting program. The membership of BioFabUSA is diverse in expertise, interests, and business plans. The initial rounds of consultation engagements will, in composite, help define the cadence and identity of the future BioFabConsulting services. These consulting services seek to support this diverse group as part of the larger mission of seeking to support existing industries and create 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 roughly a quarter century of domestic and international experience across the spectrum of review, policy, jurisdiction for all types of medical products—biologics, devices, drugs, and combination products.
To initiate a BioFabConsulting engagement, please email BioFabConsulting@armiusa.org . Upon contacting us, 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 consultation the client is encouraged to provide BioFabConsulting with a “pre-read” at least a week before the consultation is scheduled to occur. After the discussion, BioFabConsulting will propose an approach to addressing the overall consulting needs expressed by the client, and provide a proposed scope of work and an estimated budget (when applicable), including applicable hourly rates.