Industries Served

Andrew Warther Consulting supports pharmacy organizations and legal teams operating within highly regulated environments. Engagements are tailored to the regulatory requirements, operational complexity, and risk profile of each industry.

503A Compounding Pharmacies

Support for traditional compounding pharmacies navigating regulatory compliance, quality system development, and operational execution.

Typical engagements include:

  • Inspection readiness and remediation

  • USP <795>, <797>, and <800> compliance support

  • Quality system design and SOP development

  • Controlled substance compliance and oversight

  • Operational assessments and workflow optimization

  • Interim leadership during periods of transition or remediation

Veterinary Compounding Pharmacies

Specialized support for veterinary compounding operations navigating evolving regulatory expectations.

Typical engagements include:

  • State and federal regulatory compliance assessments

  • DEA registration and controlled substance oversight

  • SOP development and documentation support

  • Inspection readiness and remediation

  • Quality system design tailored to veterinary practice models

  • Operational assessments and stabilization support

DEA & Controlled Substances

Specialized support for pharmacies subject to DEA oversight and controlled substance regulations, where regulatory risk and enforcement exposure are significant.

Typical engagements include:

  • DEA inspection readiness and response

  • Controlled substance policy and SOP development

  • Diversion prevention program assessment

  • Corrective action planning following DEA findings

  • Gap assessments related to DEA requirements

  • Alignment of pharmacy operations with federal and state controlled substance regulations

Legal Teams Focused on Pharmacy Law and Medical Malpractice 

Independent, experience-based expert witness support for legal matters involving pharmacy operations, regulatory compliance, and standard-of-care matters.

Typical engagements include:

  • Case review and record analysis

  • Regulatory compliance assessment

  • Standard-of-care evaluations

  • Written expert opinions and reports

  • Consultation with legal teams

  • Deposition and trial testimony

All expert witness engagements are conducted with strict adherence to independence, objectivity, and professional integrity.

Retail and Non-compounding Pharmacies

Support for retail pharmacy operations focused on regulatory compliance, operational efficiency, and leadership effectiveness.

Typical engagements include:

  • State board of pharmacy inspection readiness

  • Controlled substance compliance and DEA alignment

  • Quality and compliance assessments

  • SOP development and policy governance

  • Leadership and organizational effectiveness support

  • Change management during growth or operational transition

Start-Up and Growth-Stage Pharmacy Organizations

Advisory and operational support for organizations scaling operations or launching new pharmacy services.

Typical engagements include:

  • Regulatory strategy and readiness planning

  • Quality system and SOP development from inception

  • Leadership advisory support during growth phases

  • Risk assessment and compliance framework development

  • Operational design and workflow implementation

  • Interim leadership during early-stage execution

Contact us

If your organization operates in a regulated pharmacy or legal environment not listed above, engagements can be tailored to your specific needs.

You will receive a direct response—no automated follow-ups or mailing lists.