BIO-ANALYTICAL LABORATORY EXPERIENCE
mass spectrometers
0
Over 200 validated methods
0
Over 20 dedicted laboratory scientists
0
robotic systems for automatic sample preparation
0
Over 100,000 samples analysed per year
0
3SPHARMA
Equipment:
- 4 mass spectrometers coupled with: HPLC & CE (capilary electrophoresis)
- One ICP MS
- Robotic systems for samples preparation (4 Hamilton robotics), 1 Extrahera, 1 Gilson
More than 200 validated bio-analytical methods.
GLP CERTIFIED since 2003
- Inspected by french, dutch, austrian, german, romanian, island and danish (on behalf of ema) authorities over 12 european inspections till now
- 2 FDA INSPECTIONS, one in Nov. 2013 and one in April 2023; both concluded
without a 483 Form !
BIO-ANALYTICAL
EXPERIENCE:
Our senior researchers have more than 25 years of experience in bio-analytical and mass spectrometry, working with:
- Small molecules
- Peptides
- Large molecules
- Chiral compounds
COMPLEX SAMPLES PREPARATION
Over 100.000 samples analyzed per year!
- Solid and liquid extraction
- Derivatization
- Chemical or enzymatic digestion
- In vitro metabolism with microsomes
Good Laboratory Practice
certified since 2003
Our bio-analytical laboratory was repeatedly inspected by EMA and by various National EU Authorities as well as by US-FDA
EMA Inspections were carried out in September 2014 and June 2024 !
Other EU Authorities conducted inspections: Austrian, Dutch, French, German, and Romanian authorities (over 14 European inspections to date)
US-FDA Inspections were carried out first in 2013 and the most recent in April 2023 !
All US-FDA inspections concluded without a 483 Form
Our bio-analytical laboratory was repeatedly inspected by EMA and by various National EU Authorities as well as by US-FDA
EMA Inspections were carried out in September 2014 and June 2024 !
Other EU Authorities conducted inspections: Austrian, Dutch, French, German, and Romanian authorities (over 14 European inspections to date)
US-FDA Inspections were carried out first in 2013 and the most recent in April 2023!
All US-FDA inspections concluded without a 483 Form
