BioFabConsulting
Regulatory Consulting Services for Regenerative Medicine
The path from early product development to the commercialization of advanced therapies and medical devices in the field of regenerative medicine is challenging to navigate. The regulatory landscape for cells, tissues, and organs, continues to evolve as scientific research and innovations propel the industry forward. In this dynamic environment, therapy developers require an experienced and trusted partner capable of skillfully guiding them through the regulatory process.
Why Choose BioFabConsulting for Regulatory Guidance?
BioFabConsulting offers a comprehensive and adaptable array of regulatory consulting services to expedite development timelines while mitigating risk. Our team’s extensive experience and expertise provide invaluable guidance through the ever-changing regulatory landscape.
BioFabConsulting works with innovators to address regulatory needs by delivering flexible levels of support. Our services include:
- Regulatory strategy review and gap analysis.
- Development of comprehensive regulatory strategies.
- Preparation for and active participation in agency consultations.
- Authoring, review, and submission of applications.
- Proficiency in full eCTD submissions.
- Review of quality systems and Standard Operating Procedures.
- Expertise in preclinical and clinical trial design.
- Regulatory training.
The road to regulatory success in the field of regenerative medicine can be daunting. BioFabConsulting is a trusted guide to help ensure safe and timely delivery of transformative therapies to those who need them most.
Regulatory Bootcamp
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.
Commercialization
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
Decades of Experience in Key Areas
- Over 40 years of experience in preclinical and clinical trial design.
- More than 35 years of expertise in CMC (Chemistry, Manufacturing, and Controls) and QA/QC (Quality Assurance/Quality Control).
- A quarter-century of regulatory experience, including FDA interactions.
- A track record of successfully completing over 30 consulting projects.
Richard McFarland, PhD, MD
To initiate a BioFabConsulting engagement, please email biofabconsulting@armiusa.org. The team will provide you with available dates and times to schedule a session 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.
