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We have a dedicated Quality Assurance Department to ensure that your projects will receive the highest level of quality by implementing Quality Management Systems. Our Quality Assurance Department is equipped with comprehensive set of standard operating procedures. Our quality assurance team has competency of predicting and preventing all non-compliances at the early stages of development to ensure data integrity and accuracy. Our quality assurance team have the approach to implement the quality management system by understanding the need for required compliance as per regulatory requirement.

This department is completely independent and provides the support to project teams to conduct high quality clinical research. QA department often assist in laying down standards, identifying service providers to be audited, for instance laboratories, drug packaging and supply vendors. They have all required technical expertise to ensure that the appropriate quality systems are in place to provide utmost data quality and integrity in accordance with ICH GCP, Protocol, SOP and regulatory requirement.

QA departments also identify the internal procedures of the trial will be audited from initial study design, site and data supervision, statistical evaluation, and the final CSR. This is accomplished by internal audits coupled with site audits to ensure compliance with ICH GCP, Protocol, SOP and regulatory requirement.

We are specialized in managing following quality assurance activities during entire project management cycle:

  • Management of The Quality Systems
  • Conduct and Reporting of Clinical Trial on Site Audits
  • Vendor Qualifications
  • Conduct and Reporting of Mock Regulatory Onsite Inspections
  • Investigator Training for Management of Inspections by Regulatory Agencies
  • SOP Preparation
  • CAPA Implementation and Compliance