Vitalea has an evolved and well tested 21CFR part 58 GLP compliant Quality System
Industry Standard Report Templates
Extensive Internal QC procedures prior to report initiation
Proven Track Record
Many successful Client Audits completed by all sizes of pharmaceutical and biotechnology companies
We design our systems for 21CFR part 58 compliance and following the FDA and ICH guidance for Bioanalytical Method Validation. We have written the most extensive review paper on the "Validation of the AMS method for Pharmaceutical Science". This paper is available upon request.
Vitalea is at the forefront of defining the QC/QA process for AMS analysis and has the only AMS instrument validated to the GLPs for regulated clinical work.
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A subsidiary of Eckert & Ziegler Isotope Products
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