• FDA Sequencing

    FDA sequencing is a term used by some US sequencing suppliers to refer to DNA sequencing performed in compliance to GLP and  GMP regulations. Avance Biosciences chooses to describe its sequencing services for the purpose of regulatory submission as GLP DNA sequencing or GMP DNA sequencing due to the fact that some of our clients are not under US FDA jurisdiction.

    FDA Sequencing
     
Your regulatory submission project is so important to you and your organization that it is critical to select a reliable service provider for your next "FDA sequencing" project. Avance Biosciences has the technical expertise, GLP and GMP quality system, regulatory compliance experience, 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 “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.

Key Features

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?

Contact Us

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.

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Request A Quote

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.