James Mullally Email

VP, In Vitro Diagnostic Regulatory Affairs . MCRA

Current Roles

Employees:
278
Revenue:
$69.8M
About
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading advisory firm to the neuro-musculoskeletal industry with growing experience in other specialties. Founded in 2004, MCRA is headquartered in Washington, DC, with offices in New York, NY, and Manchester, CT, has more than 50 team members, and serves over 400 unique clients globally. The true value of MCRA is the integration of six business value creators for orthopedic & other medical/surgical specialties: regulatory, reimbursement, clinical research, intellectual property, compliance, and quality assurance. MCRA provides “first-in-class” services through its superior knowledge base, global surgeon and physician relationships, and deeply experienced management team. Additionally, MCRA recently started Specialty Healthcare Advisers (SHA), which specializes in healthcare provider consulting. MCRA’s many years of expertise in clinical, reimbursement, regulatory and compliance to provide our clients with a unique 360? integrated perspective. Depending on client needs or goals, MCRA provides clinical trial enrollment strategy and data collection, regulatory strategy, submission and execution, specialty coding & reimbursement recommendations, RAC audit preparedness and defense, Medicare pre-determination assistance, and other services. MCRA’s core clientele are orthopedic spine and biologic medical device companies, private equity firms, CROs, and law firms, and we have an increasing percentage of clientele from other healthcare industries.
MCRA Address
803 7th St NW
Washington, DC
United States
MCRA Email

Past Companies

MCRAVice President, In Vitro Diagnostic Regulatory Affairs
FDAAssistant Director, Division of Chemistry and Toxicology Devices
FDAScientific Reviewer at FDA, Division of Chemistry and Toxicology Devices

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