Quality
Strengthening pharmaceutical quality systems and operational execution.
- Quality Systems
- QA / QC Laboratory Operations
- OOS/OOT Investigations
- CAPA & Deviation Management
- Batch Record Review
Pharmaceutical Quality & Compliance Expertise When It Matters Most
Supporting pharmaceutical and life sciences organizations with Quality, Data Integrity, GMP Compliance, Inspection Readiness, and sustainable Compliance Remediation.
Who we are
Senior-Level Quality & Compliance Support
José García Consulting LLC provides experienced pharmaceutical Quality and Compliance support to organizations facing complex regulatory, operational, and remediation challenges.
With more than 26 years of pharmaceutical Quality experience, José García brings hands-on expertise from laboratories, manufacturing floors, and Quality Systems, and helps organizations implement sustainable solutions that work within their operations.
More about José →Compliance solutions must be scientifically sound, operationally practical, and sustainable.
What We Do
Data Integrity
Protecting the reliability, completeness, and integrity of regulated data.
- ALCOA+
- Data Integrity Assessments
- Audit Trail Governance
- User Access Controls
- Electronic Records & Signatures
Compliance Remediation
Turning regulatory and compliance gaps into sustainable corrective actions.
- Compliance Gap Assessments
- Regulatory Remediation
- Quality System Remediation
- CAPA Effectiveness
- Investigation Remediation
Engagements
When Organizations Call Us
After regulatory observations
When a site needs experienced support assessing and addressing identified compliance gaps.
Before regulatory inspections
When leadership wants an independent assessment of inspection readiness.
When Data Integrity concerns arise
When documentation, systems, audit trails, access controls, or behaviors require assessment.
When CAPAs are not demonstrating effectiveness
When corrective actions require independent effectiveness evaluation.
Facing a Quality or Compliance Challenge?
Let’s discuss your organization’s Quality, Data Integrity, inspection readiness, or remediation needs.
Discuss Your Compliance Needs