DEVELOPING INNOVATIVE STRATEGIES
DELIVERING RESULTS
WHO WE ARE
The Bruder Consulting and Venture Group is comprised of three synergistic elements. We have a core Team of personnel with deep industry experience, Affiliate Firms whose expertise complements our own, and world-renown Special Advisors from the academic research and clinical communities.
WHAT WE DO
From early concept development, through regulatory approval, product launch and reimbursement, we're equipped to provide strategic and tactical support to help you achieve your goals. Our Team is experienced in the continuum of product lifecycle management, including strategic partnering, asset purchase and sale.
OUR CLIENT BASE
We have helped start-up, development stage, and some of the world's largest medical device, biotech and pharmaceutical companies achieve their goals effectively, efficiently, and economically. Come see the diversity of our Team's experience, our clientele and customer testimonials.
Do you market or use “Regenerative Medicine” procedures in your clinical practice or business? If so, you may be at risk of being sanctioned by the FDA, FTC or your State Medical Board!
Let us help you navigate the significant risks associated with the marketing and use of HCT/Ps and Orthobiologic products such as Stem Cells, PRP, BMAC, Cell Therapy, Amnion, Adipose Tissue, Exosomes, SVF and more. The formal “discretionary period” of FDA’s enforcement actions for physicians and sponsors using HCT/Ps will end in 2020, however FDA has already begun issuing dozens of Warning Letters to doctors, clinics and companies. With our experience serving on the FDA Advisory Panel for Human Cell, Tissue and Gene Therapy products, and decades of product development, regulatory and marketing success, we will help you understand the rules and penalties that apply to the use of these products in your practice. Following review of your web site and marketing materials, we will guide you in ways to minimize your risk of receiving an FDA Warning Letter, an FTC Summary Judgment, or License disciplinary action from your State Medical Board. For more information on how we can help protect your practice from costly and embarrassing punitive actions, contact us at compliance@bruderconsulting.com.
