Guidelines

Guideline on Good Clinical Laboratory Practice

FyoniBio is certified according to ISO 9001 and offers a wide range of bioanalytical services under good clinical and laboratory practice (GCLP) standards.

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Guidelines on Establishment and Validation of Bioanalytical Methods

For establishment and validation of our bioanalytical methods we apply the current international bioanalytical guidelines of ICH, FDA and EMA.

ICH Guideline

FDA Guideline

EMA Guideline

Guideline on Validation of Computer Systems

In our company all computer systems used in clinical studies are validated according to GAMP 5.

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