Our FDA Submission Services

MCRA performs an array of services, including, but not limited to, international regulatory approvals, new product acquisitions and transfer of ownership, adverse event reporting, site registrations, device listing, & acting as US agent for foreign companies. MCRA’s integrated approach allows clients to see immediate clinical trial enrollment momentum. MCRA’s FDA submission and annual update experience includes:

  • 510(K)
  • IDE
  • PMA
  • IND
  • BLA
  • De Novo

With any submission process, MCRA’s distinguishing factor is that our integrated services provide a full scope assessment that enables our regulatory consulting team to quickly and accurately guide our clients through the most challenging submissions. 


Our FDA Submission Experience

Our experience drives successful FDA submission processes. With both industry leading and direct FDA experience, MCRA’s regulatory consulting team has the experience and confidence in navigating the FDA submission process. MCRA can lead projects or work with internal teams to prepare and submit documentation to effectively address regulatory concerns and minimize additional deficiencies. Today, MCRA is the leading advisor for neuro-musculoskeletal PMAs. This know-how is increasingly important as regulatory approval processes become more stringent. MCRA's regulatory consulting team works with its clients to review, prepare, and submit the required documents to effectively address FDA regulatory concerns and minimize additional questions.

Download Regulatory Spine PMA Case study 


Contact a Regulatory Affairs Expert

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Glenn Stiegman

Glenn Stiegman

Senior Vice President, Clinical & Regulatory Affairs