Amarex Passes Taiwan FDA GTP Audit: Result Is a Resounding “No Findings”
Germantown, MD, USA (September 16, 2021) – Amarex Clinical Research, LLC, an NSF International company, announces a “no findings” result of a Taiwan Food and Drug Administration (TFDA) audit of its Taipei-based affiliate last month. The Good Tissue Practice (GTP) inspection was conducted for an Amarex client’s Phase II study of an investigational cellular product, which is required to initiate all cell therapy trials.
“Receiving no findings or warning letter rarely happens because of the magnitude of constituent parts to a trial and, not to mention, the thoroughness of the auditors,” Amarex’s President and CEO, Dr. Kazem Kazempour commented. “Our impeccable track record with regulatory agencies can be credited to the seriousness with which we have written, designed and maintained our SOPs. They are the foundation for effective regulatory compliance. We equally weigh our processes for documentation, ongoing updates and staff training of SOPs.”
Moreover, Dr. Chia-Hua Maggie Ho, COO of Amarex Taiwan, stated, “We make a point of knowing where other CROs fail because we won’t sacrifice our client’s budget or timeline. Many objectionable conditions or practices are the results of insufficient monitoring, failure to correct investigator compliance issues, accountability issues regarding treatment and failure to obtain pre-approvals. It is our responsibility to help our clients achieve a successful trial outcome, and that depends heavily on precision.”
The investigational product (IP) for this study is cell and gene therapy (CGT) to treat spinal cord injuries. CGT products offer promising potential for addressing unmet medical needs. There is pressure to expedite the approval process; however, variability and customizability of CGTs are accompanied by new and unique technical and scientific challenges.
With more than 15 years of experience working on 35+ CGT products, Amarex can provide regulatory and full clinical trial services for a wide range of CGTs. Amarex experts have the experience and knowledge to tackle any challenge that arises in CGT product development.
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