Successfully cleared 15th USFDA AuditSpare Stability Sample Storage facility available     

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Your Partner in Delivering Excellence

Quality Assurance

Quality is integrated into all of our practices. The Sitec QA team interacts directly with clients to understand the specific requirements for their clinical study or drug development project. Together, our quality and regulatory affairs specialists oversee conformance with these client requirements and any applicable regulations such as DCGI, EMEA, MCC, WHO, US-FDA regulations, and other applicable international agencies’ regulations during each stage of the study. Our experience and oversight ensures that our clinical and bioanalytical services comply with applicable Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and International Conference on Harmonisation (ICH) GCP guidelines (E6).

As part of our commitment to continual improvement, we measure, assess and report quality data and seek ways to continually improve quality performance and results. According to industry best practices, our corrective and preventive action (CAPA) process ensures we investigate significant out-of-specification events, deviations and discrepancies, report the findings and conclusions of the investigation and implement and document corrective actions. We maintain preventative maintenance and calibration programs, as applicable, to ensure operational equipment is appropriately maintained and operating as defined.

Quality Assurance Services includes: Auditing, Validation, Regulatory Inspections

With more than 350 skilled professionals & 82 beds at 1 centers located in India, Sitec can deliver the project on time with highest of quality standards.