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
- Nally, J.D., ed. (2007). Good Manufacturing Practices for Pharmaceuticals (6th ed.). CRC Press. p. 424. ISBN 9781420020939.
- 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™, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!
