QUALITY ASSURANCE DEVELOPMENT
REGULATORY COMPLIANCE
GOOD MANUFACTURING PROCESS
About Us
My name is Alan Smith and as the principal and proprietor of QA-GxP.com, my goal is to contribute to your pharmaceutical or medical device company's executive team by creating Quality Management Systems to enhance operations, quality and efficiency while reducing corporate risk exposure and associated cost. At the same time, using my expertise on a consulting basis reduces your financial commitment for an executive-level QA leader to less than the cost of most QA Managers while providing proven experienced leadership that has served over 150 FDA regulated companies over the past 20 years.
My leadership experience is in the highly regulated FDA/DEA quality and regulatory compliance arena.
My business experience is bringing executive-level quality-focused leadership to FDA regulated business leaders reducing for your firm the full-time headcount cost of an executive-level GxP professional. Compensate by the project as we go, and only for agreed to services.
Work with one of the best pharmaceutical QA leaders in the US
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GxP Quality System Support Consulting
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Decades of Quality Assurance Leadership & Direction
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Support for Pharmaceutical and Medical Device Companies
▪️ Are you a startup needing help establishing or improving Quality Assurance?
▪️ Perhaps you're struggling with quality or regulatory issues and need an expert to assist?
▪️ Do you need outsourced audits of your supply chain?
▪️ Do you need a temporary Florida certified Designated Representative?
My goal is to maximize your overall company reputation, with alignment to regulatory requirements - ultimately supporting your patients health. Beyond Quality Assurance, I have helped clients resolve regulatory issues with the FDA, State Boards of Pharmacy, DEA, and DOJ.
Click on the link below to see how we can support your business.