Select a Vendor
Consider the following points when you are ready to select a “FDA sequencing” vendor for your next project:
- Does the vendor have a GLP/GMP quality system? Ask for a copy of its quality manual.
- Does the vendor perform sequencing at 4-fold coverage for each base pair (2-fold coverage on each DNA strands)?
- Has the vendor validated its sequencing method per ICH guidelines? Ask for a copy of its method validation summary report.
- Perform an on-site quality audit or, at the minimum, perform a paper audit with a complete GLP quality questionnaire.
- Sign a Non-disclosure agreement before sharing sensitive project information.
- Avoid “black-box” organization where no information is communicated until the project is done, or in big trouble.
- And lastly, check if the vendor’s lead study director or study manager has the experience and reputation in the industry. A quick linkedin profile search will do the trick.
Avance Biosciences offers “FDA sequencing” services with the following characteristics:
- Two-fold coverage on both DNA strands (4-fold coverage total)
- Sequencing methods validated per ICH guidelines
- FDA 21 CFR Part 58 and OECD GLP compliance
- FDA 21 CFR 210/211 compliance
- FDA 21 CFR Part 11 compliance
- Most experienced staff in the industry
- Reports readily accepted by regulatory authorities
- Independent quality unit assuring regulatory compliance
- Weekly report on project progress
- Open communication between our study directors and clients
Need more info?
We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a quick message with your questions to find out what Avance can do for you.
Ready to get started?
Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.