Regulatory Advisory Services We Offer

  • Regulatory landscape assessment
  • Gap analysis
  • Pre-clinical / clinical test plan and anticipated timeline
  • Letter-to-file consult and review
  • Due diligence services
  • FDA 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.

Regulatory Advisory Services for FDA submissions on medical devices by MCRA

 

Contact a Regulatory Affairs Expert

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Glenn Stiegman

Glenn Stiegman

Senior Vice President, Clinical & Regulatory Affairs