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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14/06/2021 15:46

Challenges in development of robust analytical methods for the quantitation of low molecular weight compounds by LC-MS/MS

Method development can be considered one of the most challenging task in a Bioanalytical laboratory. When working with LC-MS/MS and low molecular weight drugs, low degree of ionization, poor fragmentation, higher presence of isobaric compounds or analyte loss due to their high volatility can get in the way of a successful method development.

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04/06/2021 11:22

Qualification of a method for the measurement of a potentially therapeutic protein

A recent project completed by Anapharm involved qualifying an analytical method for the measurement of a therapeutic protein in human skin tissue. The protein of interest is one that is expressed ubiquitously in a number of tissues and cell types.

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30/10/2020 12:49

Successful WHO Inspection

Anapharm Bioanalytics is proud to announce that it has successfully undergone World Health Organization GCP/GLP compliance inspection at its Barcelona based bioanalytical lab

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