Core competencies
Core competencies of Quasaar are:
Quality control of finished medicinal products, active substances and starting materials (excipients)
Stability and ageing studies, packaging studies
preparation of stability plans and reports,
formulation screening and compatibility tests, stress stability "forced degradation", proof of stability indicating properties of analytical methods,
stability of standards/reagents
Development of analytical methods, validation and optimisation of analytical methods, implementation and conception of technology transfer,
cleaning validation, transport validation, lifecycle management of "old methods“
Biopharmaceutical characterisation (incl. method validation),
development of discriminatory methods, solubility tests,
release of "special dosage forms", SUPAC studies
Qualification of equipment, systems, processes and air conditioning equipment,
audit preparation, qualification and auditing of suppliers,
analytical troubleshooting, testing and preparation of GMP-relevant documents
Support in the production of clinical trial materials:
- Quality control of clinical trial materials
- QC starting materials, process validation
- Qualification of rooms and equipment
- SOPs
- QA tasks and communication with authorities