Medicinal cannabinoid products developer Incannex Healthcare Ltd (ASX: IHL) has appointed Quest Pharmaceutical Services (QPS) to provide regulatory advice and manage clinical trials for the development of CannQuit and ReneCann products for addiction and immune-disordered skin diseases.
QPS was founded in 1995 to provide high-quality bioanalytical LC-MS/MS contract services. Since then, QPS has grown from a small molecule bioanalysis shop of three people to more than 1,250+ employees in the United States, Europe, India, and Asia.
Over the years, QPS has adopted additional services, including Neuropharmacology, DMPK, Toxicology, Translational Medicine, Early Phase Clinical Research and Phase II – IV Clinical Research.
QPS is currently drafting pre-investigational new drug (pre-IND) submissions for both the European Union’s European Medicines Agency (EMA) and the US Food and Drug Administration (‘FDA’) for the CannQuit and ReneCann Products. Once advice is received from the regulators over the proposed research and development programs, QPS will retain a leading role in the management of clinical trials, which will be undertaken to provide relevant evidence of safety and efficacy.
QPS is a perfect fit for us to develop these products across the globe. Not only will QPS assist us with conducting clinical research, it has been engaged to advise upon the quickest route to commercialising the products in different regulatory jurisdictions,” CEO and Managing Director, Joel Latham, said.
The CannQuit and ReneCann products are patent protected and were acquired as part of the acquisition of APIRx Pharmaceuticals (APIRx), completed in 2022. These products are being developed and manufactured by Eurofin’s Scientific.
Data collected by Eurofins on the quality and stability of the products will be key components of future regulatory packages.
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