All validated services can be performed at the GLP level. GLP (Good Laboratory Practice) ensures scientific data integrity is being protected at the research level and is applicable for experimental or non-clinical studies conducted for the assessment of the safety or efficacy. GLP-level studies provide the EPA or FDA with clear data and records regarding research that’s being done.

Service is performed for the purpose of regulatory submission under Good Laboratory Practices (GLP) promulgated by the US FDA (21 CFR Part 58 and Part 11), European, Japanese, and other regulatory agencies worldwide.

All services and platforms are offered at the GLP level unless noted otherwise. Quality statement; list of platforms that we can perform GLP tests; mention that we can develop and validate assays per clients request

References

  1. Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press. p. 424. ISBN 9781420020939.
  2. Ramakrishna, S.; Tian, L.; Wang, C.; et al., eds. (2015). “Chapter 3.: Quality management systems for medical device manufacture”. Medical Devices: Regulations, Standards and Practices. Woodhead Publishing Series in Biomaterials. 103. Elsevier. pp. 49–64. ISBN 9780081002919.

When you partner with Avance Biosciences, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss how we can support you in your project!

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Dedication to Quality

Dedication To Quality

The Avance Biosciences team is committed to strict adherence to cGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

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Extensive Experience

Open Communication

Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

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Open Communication

Open Communication

Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.

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Cutting Edge Science

Open Communication

Avance Biosciences’ cGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.

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