Laboratorio Echevarne has an accredited experience in the development and validation of analytical methods for a wide variety of molecules, covering from small synthetic chemical drugs (small molecule) to innovative biotechnological products (large molecule) within the following fields of action:

• Pharmacokinetic, Bioequivalence, Bioavailability, and drug interaction studies
• Phase I (first-in-man), Phase II studies…
• Pharmacokinetic, toxicokinetic, and bioavailability studies in preclinical trials.

Method validation is carried out in accordance with Good Laboratory Practice (GLP) Principles and the quality standards required by various Agencies (EMA, FDA, ANVISA...)

See Bioanalytical Methods List

For years, the Bioanalysis Unit of Laboratorio Echevarne has collaborated with a local animal experimentation farm certified under GLP, participating in Bioequivalence / Pharmacokinetics studies and residue studies in animal tissues across multiple matrices.

Since 1998, our analysis laboratory has held the GMP Compliance Certificate for the analysis of drug levels and their metabolites in biological specimens. This certificate is updated every two years.

• OECD, Principles of Good Laboratory Practice
• FDA Guidelines: Bioanalytical Methods Validation for Human Studies (2018)
• EMEA Guideline (2011)
• ICH Guidelines
• Notice to applicant
• VICH Guideline (2015)

• UHPLC-MS/MS Systems: Atmospheric Pressure Ionization (API) with chemical ionization and electrospray ionization systems
• HPLC-UV
• HPLC-Fluorescence
• Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
• RIA, CLIA, ELISA