Product specifications formulate / Impurity studies / Other quality studies
Analytical methods development, validation, verification and transfer
Quickly resolve various analytical problems encountered by customers
Support the quality content writing of IND and NDA registration dossiers of products
Affecting factor test (light, shock, high temperature, freeze-thaw) (1 batch of bulks and 1 batch of formulation)
Accelerated stability test (2 batches of bulks and 2 batches of formulation)
Usage condition simulating test
Long-term stability (3-36 months) (2 batches of bulks and 2 batches of formulation, reference product and placebo)
Provide raw materials and excipient testing in accordance with national pharmacopoeias
Provide package materials testing to meet national pharmacopoeia requirements including package materials compatibility related stability studies
Development of additional test items required by other customers
Support testing services environmental systems, water system verification of newly built plants
Support daily water system and environmental system monitoring services
