End to End comprehensive CRO service platform for
CMC pharmaceutical quality research and testing across the whole life cycle of pharmaceutical R&D
Pharmaceutical R&D
NOA Pharmaceutical Technology (Shanghai) LTD was founded in 2001, is one of the earliest CRO platforms to engage in pharmaceutical development and CMC (Chemical Manufacturing and Control) quality research services in China.Focused on the fields of biopharmaceuticals and pharmaceuticals for more than 20 years, with a planned laboratory space of over 30000 square meters, we have set up a drug analysis and quality control laboratory that meets the requirements of global drug registration in accordance to GMP/ISO17025 quality systems.With strict quality system, advanced instruments, unique technicial means, rich project experiences, NOA Pharmaceutical Technology is providing a one-stop comprehensive CRO service for pharmaceutical research and analysis testing for chemical, biopharmaceutical, generic, medical device, and related research and development production institutions, covering CMC pharmaceutical research, extractables and leachables (E&L) study, gene toxicity impurity research, pharmacopoeia standard testing and release, medical device and biological product research and development testing. We are committed to helping customers shorten the pharmaceutical R&D cycle and reduce R&D costs, Improve drug quality and safety.
All categories
E&L and CCIT
Extractables and Leachables (E&L) Study is to confirm through compatibility tests that the quality of drug in the selected packaging materials is stable and controllable during the validity period. Container Closure Integrity Testing (CCIT) is a method to
ICH Impurities Research (Genotoxic Impurities / Elemental Impurities, etc.)
According to the requirements of ICH Q3 and M7, study and determine the thresholds of process impurities, degradation impurities, residual solvents, elemental impurities and genotoxic Impurities.
CMC Quality Research and Drug Registration
Provide integrated CRO services for CMC quality research and testing throughout the whole life cycle of pharmaceutical research, involving various analytical method development of starting materials, intermediates, API and DP.
ICH Drug Stability Research Service
In accordance with the guidelines for stability testing of API and DP under ICH and general principles 9001 of the fourth part of ChP, the stability test of API and DP is carried out.
Pharmaceutical Testing and Release Services
Provide standard method testing (Chinese Pharmacopoeia or other Standard methods.