Analytical chemistry (GMP)
R&D AND GMP SERVICE
In product development it is essential to assure the quality of the analytical method, whether you monitor the drug, the properties of the product, impurities or excipients. The quality of the pharmaceutical product is set by the quality of the methods provided during the early phase of development. Our in-house GMP analytical laboratory with a dedicated and experienced team can provide regulatory-driven, phase appropriate analysis in support of your development program as well as across the product life cycle.
Analytical method
development
- Stability indicating method development
- Biologics analytical expertise (protein, peptide)
- Sample preparation (formulation dependent)
- Physical characterisation
- Rheology
Stress studies of
API and product
- Monitoring of impurities and degradation products
according to ICH requirements - Mass balance investigation
- Impurity investigation
Analytical method
verification/validation
- Depending on the phase of development
GMP analytical service
- Uniformity, appearance, water activity, pH, viscosity etc
- Implementation of pharmacopoeias (USP/EP/JP)
- GMP batch release
- Extra capacity for GMP quality control
Reversed engineering
- Patent infringement investigation
- Marketing claims validation
- Competitor product analysis
- Resolve manufacturer issues
CMC support
- Regulatory driven for pharmaceutical products
Generation of documentation for CTX/NDA