QbD Research & Development Lab

QbD Research & Development Lab is a premier Contract Research Organization (CRO) based in India, specializing in high-end analytical and regulatory services for the pharmaceutical industry. Established in 2012, the company operates on the core principles of 'Quality by Design' (QbD) to ensure that pharmaceutical products meet the most stringent global regulatory standards. They provide a wide range of services including formulation development, analytical method validation, and stability testing. The company is highly regarded for its regulatory track record, having cleared multiple USFDA audits with zero 483 observations, most recently in March 2023. They serve a global clientele, providing specialized testing such as Nitrosamine impurity analysis, Extractables and Leachables (E&L) studies, and In Vitro Release Testing (IVRT). With a team of over 90 experts and state-of-the-art facilities in Thane, they support the development of complex generics, injectables, and novel drug delivery systems.