Quality Management Systems

• Process Development: Quality Manual, Process Maps

• Program consultancy; Audit, Risk, Quality Oversight Plans

• Training: Investigator Meetings, GCP, GCLP and GDP

• Sponsor Inspection Readiness / Mock Inspection

• Regulatory Inspections (USFDA, EMA, Health Canada, MHRA, MPA, CFDA, French HA, German HA, DCGI, ANVISA)-For Clinical Trials