LUNARIA spol. s r.o. Information

LUNARIA spol. s r.o. (Ltd) is a private pharmaceutical Contract Research Organization (CRO) specializing in the analytical R&D and ICH stability studies of pharmaceutical products.We can suport you with number of analytical techniques you need to develop new solid and liquid dosage form formulations. Main activities: ICH Stability Studies with GMP manufacturing licence and FDA approval Photostability in accordance with ICH Q1A + ICH Q1B, automated Binder chamber Storage of Samples for Accelerated and Long – term Stability Studies, also 30 C/75 % RH Analytical Method Development, Validation and Testing, Pharmaceutical Pharmacopoeia Analytics in Accord with GMP, GMP manufacturing licence for human and veterinary drugs and Phase studies EU Analysis of Pharmaceutical Products, EU Test, EU Testing, EU Reanalysis and Batch Release with QP HPLC, UPLC, µHPLC, high resolution LC/MS (HR-NMR), CAD, mass balance, forced degradation studies, dissolution studies, freeze/thaw studies, microbiology and other Analytical Expertise, Submission of Dossiers in Czech and Slovak Republic.