ICH/VICH/ ANVISA compliant, Forced Degradation Studies
Microbiology with Preservative Efficacy and Microbial Limit Tests Tests (USP & Eur Ph)
Container Closure Integrity Testing by Blue dye ingression, High Voltage Leakage Detection and Laser Headspace Oxygen
APIs, Raw Materials, Oral dosage forms with small Molecules, Semi-solid dosage forms, liquid dosage forms,
Peptides, Hormones, Proteins and Polymers, Transdermal delivery systems
3000 m² GMP laboratory space incl. >320 m² stability storage capacities (from -70°C to +60°C)
State of the Art Laboratory Platform
28 HPLC, 8 UPLC and 4 GC, 1 GC/FID, 1 GC/MS, 5 LC/MS, 1 XRPD,…
80 very experienced Analysts
LIMS
Certified by local and international authorities (Germany, France, US FDA, GLP Tox 9, ICH)
Human and Veterinary medical Products
Handling of highly potent API up to HHB5, controlled drugs, and narcotics
Microstructure Characterization
Investigations and Troubleshooting Support
Environmental testing (air, water, surfaces)
EU-Release testing
ICH Stability Studies Zone I to IV (incl. Cycling-Compatibility-Photostability-Transportation Studies) and sample storage
Packaging Safety and Performance
Cleaning Validation
QP Services
Start in 1983 as internal QC-Unit (Formulation & Phase I), 1996 Opening for external Contract Services
> 200 Projects conducted per year in average
> 90% Repeat Business
State of the Art Equipment and Technologies: Chromatography Testing, NMR
Site Sophia Antipolis: Former GALDERMA Analytical Development and Quality Control Department
Partner for Biotech, Start-up, Mid-size & Big Pharma Companies
Pharmaceutical and Cosmetic Industry, API Manufacturers, Veterinary companies for integrated & Stand-alone Projects
Any stage of development : from Research, through the clinical phases and for commercial purposes
Strong expertise in Method Development
GMP Certification renewed in 2020
Drug Substances, Preclinical and Clinical Batches testing
