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Quality Assurance

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Quality Assurance consisting of experienced professionals having exposure to areas in drug development process and manufacturing can attend to multi faceted services such as:

  • Support for post submission query resolution and responses to facilitate successful approvals.
  • QMS support for studies in patients at clinical sites.
  • Report /Dossier preparation in E3 and eCTD formats.
  • Regulatory Dossier preparation

The team is committed to ensuring strict compliance to regulatory standards and dedication to high quality, accurate results which in turn facilitates swift and successful approval of sponsor/customer projects.

Quality Assurance is responsible for ensuring that all projects are conducted in compliance with Study Protocol, Operating Procedures and Regulatory & Ethical guidelines.

QA also ensures document control and oversees organizational training is in line with stated objectives.

Responsible for Archival management for all study data and reports.