04/28/2016

Anapharm Europe’s First FDA Inspections

Anapharm Europe is proud to announce that it has successfully undergone its first US FDA inspection at its Barcelona based bioanalytical lab. Anapharm Europe is also registered in accordance with FDA’s “Generic Drug User Fee Amendments of 2012” requiring “Self-Identification of Generic Drug Facilities, Sites and Organizations”. This inspections will allow Anapharm to strengthen its position in North America and continue to help its customers achieve their registration goals in the United States.

Barcelona, April 27, 2016 Anapharm Europe is proud to announce that it has successfully undergone its first US FDA inspection at its Barcelona based bioanalytical lab. Anapharm Europe is also registered in accordance with FDA’s “Generic Drug User Fee Amendments of 2012” requiring “Self-Identification of Generic Drug Facilities, Sites and Organizations”. This inspections will allow Anapharm to strengthen its position in North America and continue to help its customers achieve their registration goals in the United States. About Anapharm Europe Over the past few years Anapharm Europe has established itself as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLP-certified, ANVISA certified, GCP-compliant and FDA inspected laboratory in Barcelona. With a wide experience and a successful regulatory history, Anapharm Europe has become a stable analytical partner for its clients. Anapharm Europe’s main strengths include its strong expertise for method development and extensive portfolio of validated analytical methods, its high throughput capacity, as well as its top quality performance to deliver results within rigorous timelines at competitive prices.

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09/07/2018 11:01

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.

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02/07/2018 11:53

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.

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15/06/2018 14:08

Anapharm Bioanalytics has participated in the III Workshop on Phase I Clinical Trials

The presentation of our Bioanalytical Coordinator, Araceli Castillo, was focused on two trending topics on Bioanalysis: the final guidance on Bioanalytical Method Validation published by the US FDA on May 21st, 2018 and the progress on the new guideline ICH M10 for the harmonization of bioanalytical method validation.

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