Guidelines to Bioanalytical Services

Guideline on Good Clinical Laboratory Practice

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 on bioanalytical method validation

ICH Guideline

FDA guideline on bioanalytical method validation

FDA Guideline

EMA guideline on bioanalytical method validation

EMA Guideline

Guideline on Immunogenicity Assessement of Therapeutic Proteins

Therapeutic protein can elicit an immune response upon administration. At FyoniBio we follow the international guidelines of EMA and FDA to developed assays that assess the immunogenicity of therapeutic proteins.

EMA Guideline on Immunogenicity

FDA Guideline on Immunogenicity

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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Guideline on validation of computer systems