Training/Mock Inspection/SOP Development and Management

Training:


We provide complete as well as customized trainings on:



• Standard Operating Procedures (SOPs)
• Good Clinical Practice (for CROs, Investigators and Coordinators, CRAs and clinical trial managers)
• Computer System Validation
• GCP auditing skills
• Regulatory Inspection Preparedness

 

Mock Inspection:


• Mock GCP Regulatory Inspections
• Investigative Site Training and Preparedness
• In process Inspection Support and Facilitation
• Response creation

We have prepared and hosted inspection by various regulatory agencies including DCGI – India, UK MHRA, US FDA, EMEA, Taiwanese FDA, Vietnamese MoH, South Korean FDA, ANVISA – Brazil, WHO, MCC – South Africa and Israel – MoH. These include inspection conducted at BA/BE centers, investigators sites, CROs and sponsor location.

 

SOP Development and Management:


• Process Assessment and Mapping (Flow Chart)
• Gap Analysis
• SOPs Development and Administration

 

Other services include:

• GCP auditing and consultancy
• Management of Bioavailability/Bioequivalence (BA/BE) studies
• Validation and Compliance Services for Computer/Lab Systems
• GMP audits