Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certification which is now valid until February 26th, 2024.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been supporting our European and Latin American customers achieving their goals in Brazilian market and will gladly continue our mission of providing high-quality bioanalytical services in the coming years.
Should you have any project that might require our bioanalytical support, please do not hesitate to contact our Business Development team, at email@example.com.
About Anapharm Bioanalytics
30+ years’ experience in LC-MS/MS Bioanalysis and 15+ years’ experience in LBA assays for biologics, acknowledges Anapharm Bioanalytics as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified and GCP-compliant laboratory in Barcelona.
With a successful regulatory history, having undergone 22 successful inspections from health agencies, including FDA (14 studies), WHO GCP/GLP compliance, GCP inspections from Austria, Italy and Spain (12 studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients worldwide at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.
Anapharm Bioanalytics acquires a new high sensitivity equipment: SCIEX Triple Quad 6500+ system
Anapharm Bioanalytics’ small molecule division continues to expand its capabilities with the acquisition of a new LC-MS/MS equipment tailored for method development and validation of high sensitivity assaysREAD MORE
New UPLC-MS/MS bioanalytical method for quantification of Glycopyrronium and Indacaterol
We are glad to announce that a new method has been successfully developed and validated for determination of Glycopyrronium and Indacaterol in human plasma by LC/MS/MS with a calibration range of 1-200 pg/mL and 2-250 pg/mL, respectively.READ MORE
Challenges in the Detection of Metabolic Biomarkers Using a Multi Plex Assay
A 5 Plex method for the detection of metabolic biomarkers in human plasma was developed using the U-PLEX technology on the MSD platform.
The complexities surrounding this method were the establishment of endogenous QCs for each chosen biomarker and evaluating the potential use and need for buffer QCs vs matrix QCs where applicable. Additional challenges were faced while trying to ascertain a single minimum required dilution to enable accurate quantification of all biomarkers simultaneously, encompassing the different detection ranges and limits for each biomarker.READ MORE