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Regulatory Support

Whether you need assistance clearing your medical device with the FDA or help answering warning letters, 483's or audit findings, we have the experience to put you at ease.

Regulatory Strategy for 
FDA Clearance

To clear a Medical Device you need an effective plan and thoughtful advisor to guide you every step of the way.   We can help you get your product to market 


Fractional Regulatory Affairs Manager

Do you find yourself in need of an RA expert but not ready to hire someone full-time?

Our fractional RA manager or Advisory Retainers might be for you. 

Regulatory Remediation

Do you need to respond to a 483?

Overdue for an FDA audit?

We can help get your regulatory house in order. 

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