Regulatory Guidelines

relevant for Contract Services at Alphalyse

Good Laboratory Practise (GLP)

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring

Assay Validation

EMEA - Guideline on Validation of Bioanalytical Methods, draft 2009

FDA - Guidance for Industry, Bioanalytical Method Validation, 2001

Biologics Characterization

EMA - Manufacture, Characterisation and Control of the Drug Substance

FDA - Guidances on Drugs, Vaccines & Biologics

ICH - Quality Guidelines