Quality
Melbourn Scientific is cGMP compliant and is regularly inspected by the FDA and the UK MHRA.
Melbourn Scientific operates its entire facility to the standards of Good Practice as monitored and inspected by the MHRA in UK, FDA in the United States of America and government regulators from other countries who need to be assured of the quality of data produced at Melbourn Scientific.
Our approach to quality has meant that during four inspections by the FDA (against GMP as part of client PAI) in recent years we have not had a 483 or ‘significant deficiency’ noted.
Quality By Design
As a specialist provider of quality data our ethos is to build quality into every stage of our processes and procedures. Our unique approach to data generation and in-process quality control ensures our data are right first time, every time.
With involvement from clients in the early stages of every project we aim to identify and build report templates in the format you require. This coupled with our unique data authorisation processes mean that we are able to provide your fully approved data in the final report format as the project progresses, typically 48 hours after data generation. A final report is available apprx 3-5 days after project completion with Certificates of Analysis available sooner.