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