We end FDA regulatory status nightmares and certification headaches that create financial drain and threaten your business.

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Regulatory Applications

With 13 years of experience we specialize in getting your applications done on time and on budget, plus we…


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Risk Management

A well-established Product Safety Risk Management Program goes a long way to ensure high performance and compliance are sustained so you stay on track…MORE >>


Remediation Support

Don’t let that FDA 483 or Warning Letter  throw you off – we can help. After 13 years of experience we can get you back on track quickly and…