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.
Government Funding & Business Consulting
Prudent regulatory strategy should not be developed in a vacuum because numerous influences, both internal and external to an individual developer, influence the assessment of approaches to meeting regulatory expectations. BioFabConsulting leverages our broad expertise when providing strategic regulatory advice to clients, including ARMI’s expertise in manufacturing, grantsmanship, business operations and entrepreneurship, in order to tailor our advice to the realities facing each individual client. This additional, non-regulatory expertise is also a resource for BioFabConsulting clients.
Achieving any degree of regulatory fluency can be a long process that is most often acquired through painful trial and error while developing therapeutic products. BioFabConsulting offers a two-day Regulatory BootCamp designed to provide those with little or no experience in FDA regulations with a firm foundation in biologics/drug and medical device regulation. The course goes beyond timelines and regulations and emphasizes the rationale behind and strategy for FDA regulations. Bootcamps are taught by BioFabConsulting consultants with extensive experience on both sides of the regulatory curtain.
ARMI BioIndustries is the full-service development, manufacturing and commercialization operation within the Advanced Regenerative Manufacturing Institute (ARMI). We provide developers of engineered cells, tissues and organs a comprehensive range of services covering process development, deep tissue and material characterization, clinical manufacturing and regulatory support.
How to Engage BioFabConsulting
BioFabConsulting’s Principal Consultant is Richard McFarland, PhD, MD. He is also Chief Regulatory Officer of ARMI. Dr. McFarland and his team have domestic and international experience regarding the review, policy, jurisdiction and manufacturing strategy for medical products (biologics, devices, drugs, and combination products) relevant to tissue engineering and regenerative medicine applications.
Richard McFarland, PhD, MD
Click on the button below to initiate a BioFabConsulting engagement. The button links to the BioFabConsulting scheduling page that shows the team’s availability. You may choose the date, and time that works best for you.
Initial consultations are free of charge to ARMI | BioFabUSA members, and are designed to assess a potential scope of your BioFabConsulting relationship.
To help ensure the most productive initial consultation, the client is encouraged to provide BioFabConsulting with a non-confidential “pre-read” document at least one week before the initial meeting is scheduled to occur. During this discussion, BioFabConsulting will propose an approach to addressing the client’s consultation, a scope of work and an estimated budget for the work proposed.