MTR Quality Assurance systems are supported by our Quality Policies.

MTRL has become and continues to develop as a center of excellence in the execution of BA/BE studies through effective implementation of Quality Management System aligned with International Quality Standard guidelines.

Quality Policies

To achieve excellence in deliverables with Quality compliance in System,and credibility of data to our customer.

Quality policy focus

• Create ownership, Co-operation and Teamwork.
• Complete implementation of a Firm and Robust System.
• Confirm compliance with Client and Regulatory Requirements.
• Construct and enhance a culture of Continuous Improvement.

Quality Objectives

We have established the following Quality objectives in our organization to achieve excellence in Designing, Performing and Reporting of BA/BE studies.

• Implementation and adherence of Standard Operating Procedures (SOPs).
• Comply with applicable Regulatory Guidelines and Timeline.
• Internal audits at regular intervals.
• Implementation of a CAPA system with root cause analysis.
• Incessant training of personnel including assessment and compliance controls.
• Adherence to Ethical and Social Responsibility.
• Increase our Customer Focus and Gratification.

Quality Assurance:

• Our Quality and Compliance professionals work to ensure our clients move forward by maintaining Quality, Integrity, and Accuracy of data for each clinical study undertaken at MTRL.
• QA team has experience in regulatory guidelines, best practices related to quality system and in handling inspections of various regulatory authorities viz.. DCGI (India), USFDA (United States of America), TPD (Canada), EMEA (Europe), MHRA (United Kingdom), ANSM (France), WHO (Geneva), ANVISA (Brazil), NPRA (Malaysia), TGA (Australia).