PharmaAnalytic further supports Quality through the efforts of supporting Regulatory Compliance, reviewing quality systems, outcomes and regulatory responses. Additionally, services are provided to directly support the Regulatory Process across the broader scope and aiding in responses and submissions.
Auditing & Gap Assessment
Quality Systems
Data integrity
Investigations
Personnel, Knowledge & Skills
Processes
Programs
Protocol, Reports
Inspection Readiness
Systems Review, Training, Mock Interviews, Coaching
Risk Analysis
FMEA
Remediation
Technical Reports
Policies, Procedures, SOPs
Reports (e.g., APR, DHF, DMF)
Regulatory Documents (e.g., FDA, HC-SC, EMA, ISO)
Training