QbD Research & Development Lab

QbD is a trusted global partner providing analytical testing and regulatory support to pharmaceutical and biopharmaceutical companies at every stage of development and commercialisation. As a USFDA-approved testing partner, QbD delivers high-quality, compliant solutions aligned with international regulatory standards. Its comprehensive service portfolio includes pharmacopoeial studies, extractables and leachables studies, nitrosamine analysis, biomolecular characterisation, elemental impurity testing, method development and validation, stability studies, in vitro release testing (IVRT), and specialized inhalation and device-related evaluations, such as MDI and DPI studies and nasogastric compatibility studies. With advanced infrastructure, strong regulatory expertise, and deep technical insight, QbD empowers clients to meet quality requirements confidently, optimize development timelines, and achieve successful global regulatory approvals.