Regulatory Compliance & Operational Consulting
For Healthcare, Sterile Compounding & Pharmaceutical Environments
Who We Serve
Hospitals & Health Systems
Medication safety, diversion prevention, Joint Commission readiness, sterile compounding compliance.
Clinics & Medical Practices
Sterile compounding compliance, hazardous drug handling, consultant pharmacist services, Board of Pharmacy licensing support.
Pharmacies
USP compliance, Board readiness, cleanroom design, policies and procedures, education, probation consulting.
Architects, Engineers & General Contractors
Regulatory application to design,, usability design consultation, cleanroom build collaboration, BOD review, specifications guidance.
503B Outsourcing Facilities
CGMP systems, FDA remediation, SOP development, facility compliance, inspection readiness. adverse event handling.
FDA Drug Manufacturers
Including CDMO and Virtual Manufacturers: CGMP system design, FDA remediation, SOP development, compliance audits, vendor assessments.
Core Services
About Blue Ink
Blue Ink Consulting was founded by a former California Board of Pharmacy inspector, with decades of operational experience across a wide array of healthcare settings. She recognized the gap in industry expertise from both the regulatory and operations side. Blue Ink brings decades of operational and compliance experience into all projects and services.
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Blue Ink only hires consultants with unique training and credentials for compliance project management, auditing, investigations, risk assessment. Consulting work is data driven and industry research supported. Solutions are fiscally conscious and long term outcome focused. Blue Ink deploys the use of interactive analytics tools to support assessments and auditing.