Our FDA Submission Services

MCRA develops and reviews a variety of regulatory submissions for FDA.  From the beginning discussions with FDA to the marketing submission, MCRA can develop, write, and review all FDA submissions.  Often starting with the pre-submission document and continuing into the IDE or IND, along with all the reports and supplements, and ending with the marketing submission.  MCRA has experience in writing the following submissions:

•    Pre-Submissions
•    510(k) (lowercase “k”)
•    IDE
•    PMA
•    IND
•    BLA
•    De Novo
•    Breakthrough Designations 
•    Reports for PMAs, IDEs
•    Materials for meetings with FDA including briefing packages, presentations, and executive summaries
 

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