Expert Consulting for Sterile and Non-Sterile Compounding Pharmacies
Practical guidance in compliance, engineering, and quality.
Our Services
Regulatory & Compliance Support
We help 503A and 503B pharmacies meet USP <795>, <797>, <800>, FDA, and State Board expectations with practical, inspection-ready solutions.
Engineering & Validation Services
Engineering-driven validation for depyrogenation, sterilization, cleanrooms, and sterile compounding equipment.
Operational Optimization
Improve workflow, personnel movement, layout, and training to enhance efficiency, safety, and daily performance.
Quality Systems Development
We build CAPA programs, SOPs, risk assessments, and documentation systems that strengthen quality and support sustainable compliance.
Why Choose Us
Specialized Expertise in 503A & 503B Facilities
We understand the unique regulatory and operational challenges of sterile and non-sterile compounding.
Clear, Actionable Guidance
We simplify complex regulations and validation requirements into steps your team can confidently execute.
Science-Driven, Practical Solutions
We blend engineering principles, compliance standards, and risk-based decision-making to create workable solutions.
Focused on Safety, Compliance & Efficiency
Recommendations are designed to enhance safety, improve workflow, and support regulatory readiness.
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