MCRA provides unparalleled strategic regulatory advisory services to medical device companies on US FDA-related activities.
Regulatory Advisory Services We Offer
• Regulatory landscape assessment
• Evaluate and provide guidance on all aspects of regulatory strategy for product development
• Early support for medical device development, biologic development, IVDs, and combination products
• Gap analysis
• Pre-clinical / clinical test plan and anticipated timeline
• Letter-to-file consult and review
• Provide clients with an ‘FDA perspective’ review of submissions and strategies
• Due diligence services
• Short and long term FDA strategy, including submission and meeting strategy
Our Integrated Approach
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.
As a small boutique firm, MCRA works closely with clients in developing ideas and providing reliable 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.