QUALITY CONTROL

Quality Assurance and Regulatory Affairs

CGMP
Accreditation by the National institute of Pharmacy and the US FDA
DMF (CTD), USDDMF
Certificate of Suitability

Quality Control

Raw materials, intermediate products, active substances and packaging materials are checked for Conformity to specifications. In the pharmaceutical development phase, analytical methods are developed and validated.
This includes the characterization of active substances and reference substances as well as stability testing of possible by-products and degradation products based on international guidelines.

Available and contracted analytical measurements / determinations	Crystallography DSC, X-Ray
Spectroscopy NMR, FTIR, UV/VIS, AAS	Particle size measurement Laser diffraction (Malvern, Helos, Sympatec) Alpine air jet sieve, microscopy
Chromatography DC, GC, GC-MS, HPLC, HPLC-MS, IC	Polarimeter