CRO consulting

  Ensuring compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and relevant regulatory standards is crucial for maintaining the integrity and quality of research in the fields of Clinical Research Organization (CRO) and Bio-equivalence centre. These standards help to safeguard the rights, safety, and well-being of research participants, as well as the accuracy and reliability of the data collected. 

We provide support to CRO and Bio-equivalence center to achieve the compliance. Support includes

• Pre-inspection Qualification audit 
• Set up of CRO/ Upgradation
• Quality management system set up 
• Training of staff 
• Gap identification, Risk assessment and mitigation plans 
• System audit 
• Method development- Bio-analytical 
• Vendor identification/assessment
• Customized audit 
• Software support
• Computer system validation