Fraunhoferstraße 18 b82152 MartinsriedGermany
Quality is key, in everything we do.
GMP compliant analysis is performed on qualified instruments and utilizes carefully developed and comprehensively validated methods. Full GMP documentation and involvement of Quality Management allows us to perform lot release analysis and generate supportive data for market approval.
Regulatory requirements for aggregates and particles
Protein aggregates and particles can be very heterogeneous in their size, ranging from few nanometers up to visible particles of > 100 μm. We at Coriolis understand that an orthogonal approach for analyzing aggregates and particles is crucial to assure the optimum stability of a formulation. Furthermore, we observe that authorities as well as customers more frequently wish such studies to be conducted in a quality-controlled environment. This ensures a maximum in data integrity, traceability and documentation.
Sincerely Pharmaceutical Tech
Client Success Team (CRM),
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Sincerely Packaging Labelling