About Pharmacy Solutions Consulting
Pharmacy Solutions Consulting provides specialized guidance for sterile and non-sterile compounding pharmacies across the United States. We support 503A and 503B facilities with practical, engineering-driven solutions that strengthen compliance, improve quality, and enhance operational performance.
Our Mission
To empower compounding pharmacies with the tools, knowledge, and systems they need to operate with confidence, protect patients, and exceed regulatory standards. We believe that high-quality compounding is built on disciplined engineering, strong quality systems, and a deep understanding of USP, FDA, and State Board requirements.
Our Approach
Pharmacy Solutions Consulting takes a practical, risk-based approach to every project:
Compliance-Focused
We interpret and apply USP <795>, <797>, <800>, cGMP, and regulatory expectations in ways that are achievable, defendable, and aligned with your pharmacy’s workflows.
Engineering-Driven
From equipment qualification to process validation and facility design, our solutions are grounded in scientific principles and measurable performance criteria.
Hands-On and Actionable
We don’t just tell you what needs improvement—we show you how to improve it with clear, step-by-step guidance your team can execute.
Tailored to Your Facility
Every pharmacy is unique. Our recommendations are built around your operations, staffing model, equipment, and compliance goals.
What We Do
We support pharmacies through every stage of their quality and engineering needs, including:
Regulatory & Compliance Support
Quality Systems Development
Equipment Qualification (IQ/OQ/PQ)
Depyrogenation & Sterilization Validation
Facility Design & Engineering Controls
Risk Assessments & Gap Analyses
SOP Development & Documentation
Operational Optimization & Workflow Design
Whether you’re building a new pharmacy, preparing for an inspection, or upgrading your existing systems, our expertise ensures you take the right steps with confidence.
Why Pharmacies Choose Us
Industry Experience
We specialize exclusively in 503A and 503B compounding—ensuring that our guidance is relevant, compliant, and aligned with current regulatory expectations.
Technical Expertise
Our background in engineering, validation, and sterile compounding operations allows us to diagnose root causes and implement lasting solutions.
Clear Communication
We make complex topics like qualification, airflow requirements, or environmental controls easy to understand and apply.
Results That Matter
Our clients improve safety, reduce risk, avoid regulatory observations, and operate with stronger, more reliable systems.
Let’s Strengthen Your Pharmacy
Whether you're navigating new USP standards, planning equipment validation, or building a more robust quality system, we’re here to help.
Schedule a consultation today to discuss how Pharmacy Solutions Consulting can support your facility.