07/09/2018

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

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

MORE NEWS

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.

READ MORE
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.

READ MORE
17/12/2017 17:13

New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone

Anapharm Bioanalytics has successfully developed and validated a bioanalytical method for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS.

READ MORE

07/02/2018

Anapharm Bioanalytics GLP Certificate Renewal

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.

MORE NEWS

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.

READ MORE
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.

READ MORE
17/12/2017 17:13

New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone

Anapharm Bioanalytics has successfully developed and validated a bioanalytical method for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS.

READ MORE

06/15/2018

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

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.

MORE NEWS

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.

READ MORE
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.

READ MORE
17/12/2017 17:13

New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone

Anapharm Bioanalytics has successfully developed and validated a bioanalytical method for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS.

READ MORE

12/17/2017

New LC-MS/MS bioanalytical method for quantification of Estradiol and Estrone

A new method has been successfully developed and validated for determination of Unconjugated Estradiol and Estrone in human plasma by LC-MS/MS with LLOQ of 2 pg/mL and 5 pg/mL respectively.

The method involves a liquid-liquid extraction procedure and a subsequent derivatization procedure. Estradiol, Estrone and internal standards are measured by reversed phase ultra-high performance liquid chromatography coupled to tandem mass spectrometry (UPLC-MS/MS).
The possible metabolite back conversion has been evaluated during method validation.
This method has been successfully used to analyze samples from different clinical studies and the incurred sample reproducibility has met all acceptance crieria.

The development of this assay adds to the list of high sensitivity methods at Anapharm together with Tiotropium, Fluticasone, Salmeterol, Formoterol or Ethinyl Estradiol.

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

06/02/2017

Octreotide

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

Octreotide

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

05/15/2017

Anapharm Europe Announces Rebranding & Laboratory Expansion

We are pleased to announce that as part of our rebranding strategy, our brand name has now changed from Anapharm Europe to Anapharm Bioanalytics.

Our rebranding project is built on many improvements we have made to our services as well as on the international growth of our business. We have recently completed the expansion of our facilities in Barcelona increasing our lab space by 50%, acquired two additional ABSciex 6500 LC-MS/MS/UPLC platforms, upgraded software and hired additional staff in order to offer our clients increased capacity and improved study timelines for both small and large molecule bioanalysis.

The name change does not affect the legal personality of the existing entity (namely Anapharm Europe S.L.U.) which retains its rights and obligations in all existing legal relationships with third parties as well as the regulatory track record achieved to date including GLP and ANVISA certifications as well as FDA and EU-GCP inspection history.
What it means for our clients is that it is business as usual. We will continue to execute projects with the same, if not better, level of excellence and quality standards you have come to experience.

Our e-mail addresses will change but our phone numbers and headquarter’s address will remain the same. You can continue to connect with us online at our new website www.anapharmbioanalytics.com.

We take this opportunity to thank all our valued clients for their continued trust and look forward to delivering great value services that meet your expectations time after time.

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

02/14/2017

Warfarin (R-(+) Warfarin, S-(-)-Warfarin)

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

Warfarin (R-(+) Warfarin, S-(-)-Warfarin)

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE

Ziprasidone

MORE NEWS

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.

READ MORE
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.

READ MORE
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.

READ MORE