Services
Quality Control
Quality Control
In our laboratory, we ensure the quality of manufactured drug products through rigorous controls of:
Raw materials and packaging materials
Bulk solutions, in-process materials, and finished products for batch release
We comply with the standards of the European Pharmacopoeia (Ph. Eur.), United States Pharmacopeia (USP), other international pharmacopoeias, or customer specifications.
Analytical Techniques
We offer a complete range of techniques for product analysis and characterization:
Microbiology
Biochemistry
Bioassays
Physicochemistry
Stability Studies
We design and conduct stability studies in all phases according to ICH standards:
Pre-registration and registration
In-use and on-going
Forced degradation studies
Analytical Methods
We develop, transfer, implement, and validate analytical methods in compliance with the most demanding international guidelines (ICH, FDA, and EMA).