QUALITY

Since 1989, Eurofins ADME BIOANALYSES has been successfully inspected by

  • ANSM, every two years
  • FDA

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

  • Good Laboratory Practice - ENV/MC/CHEM(98)17
  • 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)

GUIDELINES

* For small molecule bioanalysis:

FDA, Guideline for Industry Bioanalytical Method Validation - May 2001

EMA, Guideline on bioanalytical method validation - July 2011

EMA, Guideline on the investigation of bioequivalence - August 2010

Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

* For immunoassays and immunogenicity:

FDA, Guideline for Industry Bioanalytical Method Validation - May 2001

FDA Draft, Guidance for Industry Assay Development for Immunogenicity Testing of Therapeutic Proteins - December 2009

EMA, Guideline on bioanalytical method validation - July 2011

EMA, Guideline on the investigation of bioequivalence - August 2010

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

Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples

* For cosmetics:

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

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