Regulatory Compliance Excellence

 

 

"Remediating Your Consent Decree, Warning Letter, Multi-483s and Quality System Challenges Right First Time and Fast By Spending Less"

 

 

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We are Consent Decree, Warning Letter, 483, Quality System and regulatory compliance remediation medical device and pharmaceutical industry consultants with 30+ yrs of impressive, verifiable accomplishments in US, Europe, Japan, China, India & Mexico.

We work hands-on to help companies regain regulatory compliance Right First Time (RFT) by spending less while implementing practical, powerful solutions to risky & costly chronic Quality System deficiencies.  

Clients hire us because they believe we would give them the best chance to successfully complete their project RFT by spending less. Apparently, our collaborators/clients believe as we do that we are a great consulting company having most if not all of the following traits:

We work well both independently and in teams. We speak the language of both senior executives - who want fast both answers to burning questions and results to thorny problems, all within budget - and engineers, office/production workers, technicians - who might have vital clues for solving a chronic problem but are afraid/shy to speak-up.

Our verifiable results of having solved problems that others had considered unsolvable, our micro/macro knowledge/experience over the full life cycle of a product, both help clients regain FDA compliance and recoup their out-of-pocket consulting expenses faster than our competition.

Clients quickly stop the bleeding and significantly reduce business risk (first patient and then regulatory compliance risks) by getting results right first time and fast through our proprietary templates/methods.

We have gained the following technical, scientific, regulatory and product application knowhow for medical device and pharmaceutical industries in the past 30+ years:

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Regulatory Compliance Excellence(tm), 403 Christie Court, Stewartsville, NJ 08886 | 908-827-1715 

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