04/02/2020

Octreotide

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31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

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27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

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12/06/2019 16:28

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.

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03/31/2020

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Barcelona, March 31st, 2020

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.
Anapharm has been certified by Brazilian regulatory authority since the first inspection took place in 2011. We have since then been supporting our European and Latin American customers achieving their goals in Brazilian market and will gladly continue our mission of providing high-quality bioanalytical services in the coming years.
Should you have any project that might require our bioanalytical support, please do not hesitate to contact our Business Development team, at contact@anapharmbioanalytics.com.

About Anapharm Bioanalytics

30+ years’ experience in LC-MS/Bioanalysis and 15+ 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 20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 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.

MORE NEWS

27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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
23/01/2019 10:19

Anapharm Bioanalytics has been acredited under the Gulf Health Council

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).

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01/27/2020

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research tax credit certification (Crédit d'Impôt Recherche) for period 2020 - 2024.

This certification is key to support French biotech & pharmaceutical companies and is aligned with our mission of helping our customers to develop innovative therapies.

Should you have any project that might require our bioanalytical support, please do not hesitate to contact our Business Development team, at contact@anapharmbioanalytics.com.

About Anapharm Bioanalytics

30+ years’ experience in LC-MS/Bioanalysis and 15+ 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 20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 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.

MORE NEWS

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
12/06/2019 16:28

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
23/01/2019 10:19

Anapharm Bioanalytics has been acredited under the Gulf Health Council

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).

READ MORE

06/12/2019

Anapharm Bioanalytics’ successful FDA Inspection

Barcelona. June 12, 2019

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.

The regulatory history of Anapharm, which, besides the GLP and ANVISA certifications, includes 14 studies inspected by FDA and another 12 study specific inspections conducted by European authorities, will certainly enable Anapharm Bioanalytics to strengthen its commercial presence throughout Europe and North America and continue to help its customers achieve their registration goals.

“This is the result of the continuous efforts of Anapharm’s team to ensure day after day the highest scientific and quality standards in the work that we do” stated Anapharm’s Director of Business Development, Robert Fontarnau.

About Anapharm Bioanalytics

30+ years’ experience in LC-MS/Bioanalysis and 15+ 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 20 successful inspections from health agencies, including FDA (14 studies), GCP inspections from Austria, Italy and Spain (12 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.

MORE NEWS

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
23/01/2019 10:19

Anapharm Bioanalytics has been acredited under the Gulf Health Council

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).

READ MORE

01/23/2019

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.

MORE NEWS

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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

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

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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

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

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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

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

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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

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.

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31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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

06/02/2017

Octreotide

MORE NEWS

31/03/2020 10:03

Anapharm Bioanalytics Brazilian ANVISA Certificate Renewal

Anapharm Bioanalytics is proud to announce that it has recently (February 20th, 2020) renewed its ANVISA (Brazil) certificate. The renewed certification is valid until February 20th, 2022.

READ MORE
27/01/2020 16:02

Anapharm Bioanalytics Receives Certification for French Research Tax Credit

Anapharm Bioanalytics is pleased to announce it has renewed its French research Tax Credit certification (Crédit d’Impôt Recherche) for period 2020 – 2024.

READ MORE
12/06/2019 16:28

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