Bioanalytical
Bioanalytical
Noah therapeutics boasts a high-quality bioanalytical research department, headed by a highly experienced leader and a competent team. The department is equipped with all the standard methods that offer specialized support to drug developers in optimizing their drug candidates, assessing their safety and efficacy and meeting the regulatory standards. The bioanalytical research team has the capability to handle and support various phases of drug development, from preclinical to clinical to post-marketing studies.
❖ Bioanalytical lab spreads over 4000 square feet area in separate building.
❖ Two LC-MS/MS Systems (SCIEX 4500)
❖ Audit trail and data security systems
❖ Sample preparation laboratory equipped with centrifuges, SPE manifolds, refrigerators, vortex mixtures, pH meter, ultrasonic bath, Nitrogen evaporator and fume hoods with restricted access.
❖ Mettler Toledo Micro / Analytical balance.
❖ MD/MV of simple and complex drugs and metabolites as per regulatory requirements
❖ GLP and 21 CFR Part 11 complaint
❖ Deep Freezers -70°C, [02] & Freezer – 20°C, [01]
❖ Separate pharmaceutical refrigerators for storage of working/ reference standard and stock solutions
❖ Centralized Monitoring of Temperature
