EUROFINS ADME BIOANALYSES

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QUALITY

Since 1989, Eurofins ADME BIOANALYSES has been successfully inspected by

• FDA, in 2009 and 2017 (Inspections on bioequivalence studies)
• ANSM,(French GLP authorities for pharmaceuticals and cosmetics), every two years
• COFRAC/GIPC (French GLP authorities for chemicals), every one or two years
• ANSES (French GLP authorities for veterinary drugs), last inspection in 2015

The company designs development programs according to the latest regulatory standards and to this purpose, works closely with experts from various European Health.

REGULATORY DOCUMENTS

• OECD Good Laboratory Practice - ENV/MC/CHEM(98)17
• European Good Laboratory Practice - 2004/10/EC
• Arrêté du 14 mars 2000, France (For pharmaceutical products)
• Arrêté du 10 août 2004, France (For cosmetics)
• Arrêté du 28 janvier 2005, France (For veterinary drugs)
• Article annexe II à l'article D523-8 du code de l'environnement, France (For chemical products)

GUIDELINES

* For small molecule bioanalysis:

FDA, Guideline for Industry Bioanalytical Method Validation - May 2018

EMA, Guideline on bioanalytical method validation - July 2011

EMA, Guideline on the investigation of bioequivalence - August 2010

EMA, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples - February 2012

* For immunoassays and immunogenicity:

FDA, Guideline for Industry Bioanalytical Method Validation - May 2018

FDA Draft, Guidance for Industry Assay Development and validation for Immunogenicity Testing of Therapeutic Protein products - April 2016

EMA, Guideline on bioanalytical method validation - July 2011

EMA, Guideline on the investigation of bioequivalence - August 2010

EMA, Guideline on immunogenicity assessment of therapeutic proteins - May 2017

EMA, Guideline on immunogenicity assessment of biotechnology derived therapeutic proteins - December 2007

EMA, Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use - May 2012

EMA, Guideline for medicinal products of biotechnology-derived therapeutic proteins - December 2007

EMA, Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples - February 2012

* For dermal absorption studies:

OECD n°428 Guideline for the testing of chemicals: Skin absorption, in vitro method - April 2004

OECD n°427 Guideline for the testing of chemicals guideline: Skin absorption, in vivo method - April 2004

OECD n°156 Guidance notes on dermal absorption - August 2011

OECD n°28 Guidance document for the conduct of skin absorption studies - March 2004

SCCS Basic criteria for the in vitro assessment of dermal absorption of cosmetic ingredients - June 2010