Who we are and what our mission is

Former United States Food & Drug Career Officers

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After 30 plus years in the agency, we decided to alter direction. We now have private consulting experience totaling over 5 years helping firms with FDA issues.  We have the time and years of knowledge on how the agency conducts business. Now, we share our passion by helping firms. Our ramp up process is designed to help your firm meet FDA Inspection . Contact us for a c.v. of our consultants. Prepare your team and outfit them with the tools they need to succeed with FDA related matters such as inspections. Talk to us today about how we can support your company in CGMP, QMS and most FDA programs.

Our mission Participate in our customers  business success by meeting or exceeding compliance. 

Our Approach

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Our service includes a comprehensive consult to help identify gaps and areas of regulatory risk.,We provide a comprehensive report that includes a project plan with a mock FDA-483 Notice of Observations.  We also offer a advice that will help you get there quickly.  That’s how we ensure your success.

Why Us?

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Former career US FDA Officers with extensive regulatory experience are key in helping you meet and exceed FDA requirements. We want to give each of you the time and guidance you deserve.  Whether you’re seeking a strategic alliance with us or a special skillset, training or tool, call us today. Together we’ll create and refine your plan for success. We are here to help you with a personalized plan to fit your company.