• GLP DNA Sequencing

    GLP DNA sequencing refers to DNA sequencing performed in compliance to Good Laboratory Practice (GLP) regulations promulgated by US FDA, OECD, and other regulatory agencies around the world. A typical application of GLP DNA sequencing is to sequence patient samples in a clinical trial to validate a DNA-based diagnostic device for FDA’s 510K clearance or premarket approval.

    GLP DNA 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 GLP DNA sequencing project. Avance Biosciences has the technical expertise, GLP quality system, regulatory compliance experience, fast turn-around time, and outstanding customer service to ensure the success of your project.

Testimonials

From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor. There is for sure no comparison in the way this project was handled in the two organizations. We hope our future projects will be managed by you in the same smooth way. –Project Manager, Belgium

It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences' services to colleagues and friends. –Senior Scientist, Singapore

Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future GLP DNA sequencing projects. –Program Manager, California

 

Key Features

Avance Biosciences offers GLP DNA 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 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

 

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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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