Autor: Ivette Marrero

07/09/2018

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

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Barcelona, July 09, 2018

Anapharm Bioanalytics is proud to announce that it has recently (11th June 2018) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until 11th June 2020.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been assisting our European and Latin American customers achieve their goals in Brazilian market and will gladly continue providing high quality bioanalytical services in the coming years.

About Anapharm Bioanalytics

Over the past few years Anapharm Bioanalytics has established itself as a world class provider of bioanalytical services to international Sponsors with its strategically located, GLPcertified and GCP-compliant laboratory in Barcelona. With a wide experience and a successful regulatory history, Anapharm has become a stable analytical partner for its clients.

Anapharm Bioanalytics`s main strengths include 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.

For further details about Anapharm Bioanalytics, please visit https://www.anapharmbioanalytics.com/services/ or contact your Business Development representative at +34 93 223 8636

07/02/2018

Anapharm Bioanalytics GLP Certificate Renewal

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Barcelona, July 2nd, 2018

As part of its efforts to continue to upgrade its quality system Anapharm Bioanalytics has renewed once more its Certificate for Good Laboratory Practice Principles (GLP). The company is under GLP certification since 2003; the present certificate is valid until June 2020.

Over the past few years Anapharm Bioanalytics has established itself 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 wide experience and a successful regulatory history, the company has become a stable analytical partner for its clients. Anapharm Bioanalytics’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.

For further details, please visit https://www.anapharmbioanalytics.com/services/ or contact your Business Development representative at +34 93 223 8636.

06/15/2018

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

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Bioanalytical Method Validation: Progress and New Challenges
By Araceli Castillo, Anapharm Bioanalytics

On May 21st, 2018, the US FDA published the definitive guidance for the validation of bioanalytical methods. The document includes the comments made on the 2013 draft and reflects the progress in science and technology for the past five years.
As compared to the previous draft guidance, the structure of this new document has been improved and summary tables have been added to point out the requirements and acceptance criteria for carrying out each one of the assays. Moreover, recommendations on the documentation to be reported were also included.
As main changes, we can emphasize that the development of the methods has gained importance. Also, the sections of chromatographic techniques and LBA have been unified. These two points make this guidance different from previous bioanalysis guidelines published to date.
On the other hand, within the current regulatory framework, bioanalytical laboratories must meet the requirements of different countries in order to offer a global service and facilitate the development of a drug at international level. However, the guidelines for the validation of bioanalytical methods published in the different regions show discrepancies, not only in the parameters required, but also in the procedures for their evaluation.
In 2016, ICH took the initiative to prepare a multidisciplinary guideline for the validation of bioanalytical methods, M10, to harmonize different requirements among countries. The draft guide is expected to be available for public consultation at the beginning of 2019.
The publication of the US FDA guidance in the midst of the ICH harmonization process changes the current scenario. How this will affect the ICH draft guideline currently being discussed is yet to be seen.