1) Bioanalytical Methods: Method validation is carried out in accordance with following guidelines: United States Food and Drug Administration (FDA). Organization for Economic Cooperation and Development (OECD). As per the Standard Operating Procedures (SOPs) of Sannova and/or Sponsor.
2) GLP Bioanalysis: Latest equipment with automated technologies for high throughput LC-MS/MS analyses enables Sannova to support as simple as a pilot study to a full-fledged pivotal study. The criteria for acceptability of an assay are stringently adhered in accordance with Sannova SOPs, which were based on FDA?s guidance for Industry on Analytical Procedures and Methods Validation.
3) Data Reporting & Electronic Submissions: Biostudy reports are prepared as per FDA requirements. We also provide documentation in eCTD format.