Where 503A meets 503B — ensuring patient safety through the absolute excellence of compounded medications.
Welcome to the Alliance for Compounding Excellence. We are focused on patient safety by assuring the excellence of compounded medications.
This assurance is achieved through certification of pharmacy and physician compounders (503A) and Registered Outsourcing Facilities (503B). Our certifications are based on pertinent expectations of the respective regulatory bodies: USP Compounding Chapters, FDA's Insanitary Conditions Guidance, and CGMP entities.
Why Choose ACEExpert partnership that reduces risk, improves outcomes, and builds lasting compliance frameworks.
We go beyond basic checks. Our survey process measures regulatory compliance, identifies risk exposure, and ensures alignment with industry best practices.
We don't just report deficiencies — we provide solutions. Get explicit recommendations and a precise roadmap to improve performance and achieve certification.
Access our sister company, 503QM, at a discounted rate for specialized help with deficiencies, niche GMP areas, and quality resource management.
Dedicated expert teams for 503A and 503B regulatory environments.
ACE utilizes surveyors with vast direct experience. Our experts understand non-sterile, sterile-to-sterile compounding, workflow, facility requirements, and quality assurance.
Current Good Manufacturing Practices (cGMP) differ markedly from USP standards. Our surveyors are usually former FDA Investigators following Compliance Programs 7356.002A/002.
A three-phase approach designed to minimize workflow disruption.
In-depth interview with senior management to fully understand your organization and specific needs.
Thorough off-site review of key documents to minimize onsite time and operational disruption.
Surveyors arrive informed and ready — focused on physical processes, facility conditions, and staff interviews.
Whether you need certification or preparation for a difficult state accreditation, ACE provides the confidence to navigate the process. ACE certification demonstrates excellence to your peers, regulators, and customers.
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