Anapharm Bioanalytics has been acredited under the Gulf Health Council
Barcelona, January 23, 2019
Anapharm Bioanalytics is proud to announce that it has been recently added to the List of Bioequivalence Centres Approved by GCC, Gulf Cooperation Council (United Arab Emirates, Bahrain, Kingdom of Saudi Arabia, Sultanate of Oman, Qatar, Kuwait and Republic of Yemen).
It will certainly enable Anapharm Bioanalytics to strengthen its commercial presence throughout the Gulf area. It will also ease the regulatory pathway to register a medicinal product under before mentioned Authority for any company who conducted the studies at Anapharm Bioanalytics.
About Anapharm Bioanalytics
30+ years’ experience in LC-MS/Bioanalysis and 10+ years’ experience in LBA assays for antibodies and biomarkers, 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 19 successful inspections from health agencies, including FDA (6 studies), GCP inspections from Austria, Italy and Spain (10+ studies), as well as GLP certifications by EU authorities and ANVISA (Brazil), Anapharm has become a reliable analytical partner to support its clients at any stage of drug development from preclinical throughout all clinical stages Phase I-IV.
Anapharm Bioanalytics’ successful FDA Inspection
Anapharm Bioanalytics is proud to announce that it has successfully undergone another US FDA inspection at its Barcelona based bioanalytical lab. The inspection, that took place in June 2019, had a focus on a total of 8 studies. This was the second unannounced FDA inspection at our facilities without any observations; no 483 form issued.READ MORE
Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal
Anapharm Bioanalytics is proud to announce that it has recently renewed its ANVISA (Brazil) certificate.
The renewed certification is valid until 11th June 2020.
Anapharm Bioanalytics GLP Certificate Renewal
After the corresponding regulatory inspection Anapharm Bioanalytics has renewed once more its Certificate for Good Laboratory Practice Principles (GLP). The company is under GLP certification since its foundation. The present certificate is valid until June 2020.READ MORE