Regulatory Submission
Our GLP compliant studies are suitable for submission to FDA, EPA, USDA, or other regulatory agencies. We comply with the US FOOD and Drug Administration regulations covering GLP (21 CFR 58), the US EPA regulations covering GLP Standards (40 CFR 160), or other applicable regulations. We have established standard operating procedures (SOPs) with a comprehensive quality control/quality assurance program. Our final report can be easily incorporated into a submission to the regulatory agency.
The following records will be archived after the completion of the analysis:
- Original protocol, final report, and amendments
- Laboratory notebooks containing all raw data
- All computer-generated data burnt to electronic storage media
- Study correspondence
- Test and Control articles will be retained for up to two years.
Examples of services offered for regulatory submissions are:
- DNA sequencing
- SNP genotyping
- STR genotyping
- Site-directed mutagenesis
- Gene cloning
- Mutation detections
