Regulatory Services Offered By Indian CRO’s.

India over the last decade has come up with various developments and advancements in medical trials and in project and data management. India has been successfully able to provide cost savings of 50 to 60 percent in clinical trials. With the research discovery acquiring approximately one-third of the R&D expenses of the western medical industry, outsourcing to lesser expense countries is a wise move. With the financial and regulatory pressure expanding in the US and European medical industry, it is estimated to propel the development in the Indian clinical trial market.

All this has compelled the clinical research organizations (CRO) in India to introduce advanced clinical laboratory services that assist in disease treatment and drug development. The medical doctors and technicians’ research experiment and conduct different medical studies and experiments and review human blood sample and assesses blood samples and evaluate the impact of drugs on the blood. This apart, the CRO’s also give importance to regulatory compliance services and appropriate quality assurance. There is a separate team for regulatory services and audit compliance that is in turn supported by a vast knowledge of the local regulatory procedures and helpful associations with various regulatory agencies ensuring perfection in the clinical trial approval process. Rigid healthcare budgets, patent expiries and stricter regulatory climate are some of the essential challenges that the medical industry witnesses today.

Renowned Indian CRO’s specializing in regulatory services has completed various audits from multiple global and Indian regulatory agencies. Simultaneously, there have been study submissions from multiple countries. The vast range of regulatory services offered includes the following:

• Formulating regulatory strategies
• Replying regulatory agency queries
• Renewing Import License
• Procuring drug import licenses
• Follow-up and submissions on the application
• Tracking applications and approvals
• Submission of Clinical Safety Report (CSR)
• Safety Reporting
• Procuring NOC for export of biological samples
• Compiling a clinical trial application

In addition to that, with regards to QA Indian CRO’ s have a complete quality assurance team to manage the same with a standard quality. The team focuses on quality that permeates through the processes within the domain of each single process. In addition to that, there are thorough implementations that are carried out by the Quality Assurance and Quality Control processes. QA practices span across Bioanalytical, Clinical, Statistics, Internal Audits and Reporting by the QA team for area specific SOP compliance. Simultaneously, there are other in-house capacities that CRO’s perform and includes of components such as Site Audits, Vendor Audits, Process/System Audits, and Document Audits that includes protocol, clinical study reports and important clinical trial documents.

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