Your regulatory submission project is so important to you and your organization that it is critical to select a reliable service provider for your GLP QPCR project. Avance Biosciences has the technical expertise, GLP regulatory compliance, fast turn-around time, and outstanding customer service to ensure the success of your project.
Select a Vendor
Consider the following points when you are ready to select a vendor for your next GLP compliant QPCR project:
- Is the vendor GLP compliant? Perform an on-site quality audit or, at the minimum, perform a paper audit with a complete GLP quality questionnaire.
- Does the the vendor develop and validate QPCR methods for GLP applications per ICH guidelines?
- How does the vendor manage customer samples to ensure the integrity of precious clinical or preclinical samples?
- Has the vendor done similar work before? Check if the vendor’s lead study director or study manager has the experience and reputation in the industry.
- Avoid “black-box” organizations where no information is communicated until the project is done or in big trouble.
- Lastly, for a large clinical or preclinical trial project, it is always a good idea to send the vendor a pilot project with a few samples to evaluate the vendor’s technical capability, report format, regulatory compliance, and quality of customer service.
Avance Biosciences offers GLP compliant qPCR services with the following characteristics:
- Strong experience in QPCR assay design and validation
- Applications including absolute quantification, relative quantification, SNP genotyping, and presence/absence tests
- Methods validated per ICH guidelines for GLP applications
- Systematic approach in preventing cross-contamination from environment, reagents, and supplies
- Detailed project report including description of assay, results of the quantification, and tabulation of data
- Professional final report ready for regulatory submission
- Most experienced staff in the industry
- Weekly report on project progress
- Open communication between our study directors and clients