Quality Management

Innovate Research Quality Assurance (QA) team interacts directly with clients to understand the specific requirements for their product development project.

Our quality and regulatory affairs specialists ensure adherence to these client requirements and any applicable regulations from the U.S. Food and Drug Administration (FDA), Canada’s Health Products and Food Branch Inspectorate, European Union, ANVISA and other international agencies during each phase of the clinical trial process.

Our experience and oversight means that our services comply with Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and International Conference on Harmonisation (ICH) GCP guidelines (E6). Quality is integrated into all of our processes.

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.

AUDITING

  • Investigator sites
  • Clinical and analytical laboratories
  • Drug packaging and distributors
  • Institutional Review Boards
  • Phase I units
  • Suppliers/vendor

VALIDATION

  • Computer systems
  • Databases

 

Contact

Within India

0 120 4797021

Outside India

+91 120 4797021

G-07, Newbridge Business Centre, 1st Floor,
Inox Tower-B, Plot No. 17, Sector-16A, Film city,
Noida, India 201301

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