Experienced 503 Quality Management Consulting
Effective quality management services for 503B (Outsourcing facilities) and 503A (Compounding Pharmacies)
As with many other things there is a surprising amount prejudice against quality control , but the proof of the pudding is still in the eating . Kaoru Ishikawa
Most Requested services
Most Requested services
Most Requested services
FDA 483 & Warning letter resolutions.
USP 795 ,USP 797 & USP 800 Compliance
Personnel Training
GAP Analysis.
Root Cause Analysis.
Corrective and Preventative action.
Risk Management.
Outsourced Quality Management.
Process validation.
DQ, IQ, PQ, OQ.
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Testimonials
Most Requested services
Most Requested services
May 2021 - February 2022
In our most recent service our Principal Consultant was the primary quality unit responsible for assisting a 503A facility in California to obtain a close out letter from the FDA after the facility was investigated, subsequent to receipt of a warning letter .
Client Confidentiality refrains us from naming our Clients.
Latest FDA Animal Compounding Guidance 2022
Latest FDA Animal Compounding Guidance 2022
Latest FDA Animal Compounding Guidance 2022
List of Bulk Drug Substances for Compounding Office Stock Drugs for Use in Nonfood-Producing Animals
Sterile and Non-Sterile Compounding
Latest FDA Animal Compounding Guidance 2022
Latest FDA Animal Compounding Guidance 2022
About 503 Quality Consulting LLC
Our Experience
After 20 years in the Compounding, and multi years in the Pharma industry, our team of Pharmacists, Engineers and Scientists decided to alter direction. Now, we pursue our passion by sharing our knowledge & experience with others. Our ramp up process is designed to empower your team and outfit them with the tools they need to build and maintain a great Quality Culture in your organization. Talk to us today about how we can support your organization
Our Approach
We are about relevance and results, especially when a company is in crisis mode and has aggressive timelines Our service includes a comprehensive consult to help identify gaps and opportunities for improvement, a report that includes a plan with timelines and milestones, a cost analysis, and a schedule. That’s how we ensure your success.
Why Us?
We want to give each of you the time and guidance you deserve. Whether you’re seeking a one time solution to a problem, an ongoing alliance with the right solutions partner or a special skill set, send us an email today. Together we will create and refine your plan for success.
H.O : Wyoming
Regional Offices: California, Arizona, Maryland
Serving all 50 States USA, Canada and India