Strategic Advisory Services
MCRA is the world leading regulatory advisor to the neuro-musculoskeletal industry on U.S. FDA related activities. Whether assisting on specific subjects or executing on complex pipeline strategies, MCRA’s regulatory team is a value-add to any potential client. MCRA’s distinguishing characteristics in providing these world-class strategic advisory services is due to:
Domain specific regulatory expertise in orthopedics (general orthopedics, sports medicine, spine, biologics, trauma, new developing niches);
Mechanical engineering and biological backgrounds able to assist with pre-clinical and clinical strategies, and is able to effectively communicate these strategies to internal and regulatory constituents;
Long-term working relationships with the FDA and an instinctive understanding of FDA reporting processes and timelines; and d)
Senior level involvement.
As a small boutique firm, MCRA works closely with clients in developing ideas and providing sound judgment. MCRA’s integrative multi-disciplinary approach in offering clinical, regulatory and reimbursement services allows MCRA to consider important factors that impact the cost, timing, and success of getting a product effectively approved and paid for.
With decades of experience with both industry and FDA, MCRA understands how to navigate the regulatory approval process and provide the highest-quality regulatory strategic advisory services. These include:
the FDA and
To speak to a strategic regulatory advisor, please call 202.552.5800
MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services