What We Do

Sterile & Non-Sterile Compounding Compliance
USP-aligned support for 503A pharmacies focused on practical, sustainable compliance.Inspection Readiness & Regulatory Response
Gap assessments, documentation review, and defensible inspection support.Education & Staff Training
Aseptic technique, workflows, and documentation principles that support consistent practice.Medication Error Surveillance and Analysis
• Structured evaluation of medication error trends, near misses, and risk points within compounding workflows.
• Application of compliance and quality data to identify error drivers and prioritize remedial actions.

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Why Choose Us

Integrity-Driven Consulting
Transparent, accountable guidance focused on long-term quality, not box-checking.Expert, Practical Guidance
Recommendations grounded in regulatory intent, scientific principles, and real-world pharmacy operations.Risk-Based, Proportionate Solutions
Recommendations prioritize patient safety and regulatory intent while accounting for operational and resource realities within 503A pharmacy settings.Risk-Informed Medication Safety Perspective
All recommendations incorporate systematic identification and root cause analysis of medication errors and near misses within compounding workflows, strengthening quality systems and inspection readiness.

Baseline Compliance Assessment

Structured review of current practices to identify gaps relative to USP standards and common inspection focus areas, with prioritization based on risk and feasibility.Common Deliverables:
• Facility and workflow review
• Assessment of SOPs, records, and training documentation
• Risk-ranked findings with recommended corrective actions
• Summary suitable for owners and pharmacy leadership

SOP, Documentation, and Training System Development

Development or refinement of SOPs and associated records designed to support consistent execution, staff training, and inspection readiness.Common Deliverables:
• SOPs aligned to actual sterile and non-sterile workflows and decision points
• Procedures structured as day-to-day training and reference tools, not solely compliance documents
• Forms and logs that reinforce procedural requirements and staff accountability
• Document control structure (versioning, approvals, periodic review)
• Training alignment guidance linking SOPs to onboarding, initial qualification, and ongoing competency

Sterile Compounding Program and Staff Training Support

Targeted support to establish or stabilize sterile compounding programs, with emphasis on aseptic technique, error-resistant workflows, and ongoing competency consistent with USP <797> expectations.Common Deliverables:
• Personnel training and qualification framework
• Aseptic technique training support tailored to your PECs and workflow
• Review and refinement of gowning, gloving, and aseptic practices
• Environmental monitoring program structure and documentation support
• Cleaning and disinfection program alignment, including staff roles and documentation
• Inspection readiness support focused on demonstrating training, competency, procedural adherence, and how compounding-related errors and near misses are identified, documented, and addressed

Quality Management System Support

Support for development or refinement of quality system elements commonly evaluated during inspections.Common Deliverables:
• Deviation and investigation process design
• CAPA structure and documentation practices
• Change control for facilities, equipment, formulations, and documents
• Supplier qualification and incoming material controls
• Data integrity practices aligned with ALCOA+ principles
• Integration of medication error data into deviation, CAPA, and inspection-readiness reporting to reduce recurrence of preventable errors.

Formulation, Stability, and Testing Support

Support for formulation documentation, beyond-use dating rationale, and appropriate use of quality testing consistent with 503A practice and inspection expectations.Common Deliverables:
• Formula documentation describing composition, process parameters, and quality attributes
• In-process checks and routine quality assessments appropriate to the preparation and setting
• Beyond-use dating rationale support based on available evidence, risk assessment, and documentation expectations
• Development or refinement of internal testing procedures where applicable
• Guidance on selection and qualification of third-party analytical laboratories
• Review and interpretation of laboratory test reports, including trends and out-of-specification results
• Alignment of testing practices with SOPs, batch records, and inspection-facing documentation

Compounding Facility Design and Build-Out Support

Advisory support for the design or renovation of compounding facilities to meet USP standards and applicable state and federal regulatory requirements, with emphasis on inspection-ready layouts and error-resistant workflows.Common Deliverables:
• Review of architectural plans and proposed layouts for alignment with USP <797>, <795>, and state board requirements
• Guidance on room classifications, pressure differentials, and material flows
• Workflow and space planning to reduce contamination risk and prevent compounding errors
• Input on environmental controls, equipment placement, and cleaning access
• Pre-operational readiness review prior to licensure, accreditation, and/or inspection