Pantrone Consulting Co. Ltd. was established in 2019 and is a Contract Research Organization (CRO) specializing in cell therapy clinical trials. Pantrone is composed of a team of top-notch doctoral and master’s graduates from domestic and international universities.
Pantrone has successfully obtained multiple approvals for Investigational New Drug (IND) applications from the U.S. Food and Drug Administration (FDA), including the first Taiwan-based allogeneic chimeric antigen receptor T-cell (Car-T) therapy to receive IND approval in the United States. We provide the most professional services for clinical trials of cell products, and we believe Pantrone is your best choice for developing cell products.
Pantrone helped a biotech company in Taiwan to obtain the Investigational New Drug (IND) in of a genetically modified exosome in United States. The IND was granted by FDA within 30 days after submission. This is also the first US IND of exosome product in Taiwan. Pantrone created a record among all CROs in Taiwan again and helped our clients to achieve an important milestone again.
Pantrone helped a leading cell therapy company in Taiwan to obtain Investigational New Drug (IND) of an allogeneic Chimeric Antigen Receptor T (Car-T) cell for treating solid tumors in United States. The IND was granted by FDA within 30 days after submission. This case is also the first US IND of allogeneic Car-T product in Taiwan. Pantrone created a record among all CROs in Taiwan and helped our clients to achieve an important milestone again.
Pantrone helped a leading cell therapy company in Taiwan to obtain Investigational New Drug (IND) of Umbilical Cord Mesenchymal Stem Cell (UCMSC) therapy for Multiple Sclerosis (MS) in United States. The IND was granted by FDA within 30 days after submission. Once again, Pantrone helped our clients to achieve an important milestone.
Drafting Investigational New Drug (IND) application documents in compliance with the Common Technical Document (CTD) format required by the U.S. and Taiwan FDA.
Consult the FDA regarding the data needed to complete the IND, in accordance with existing product data and FDA guidance requirements. Leveraging our extensive experience, we have successfully obtained exemptions for certain animal experiment and product quality (CMC) data from the FDA on multiple occasions. This has helped our clients shorten development timelines and save on development costs.
We accelerate the development of new drugs by assisting clients in meeting regulatory qualification criteria, such as Orphan Drug Designation (ODD) and Fast Track designation in the United States.
Writing CSR documents in the format of the International Council for Harmonization (ICH) to comply with the regulations of the U.S. and Taiwan FDA.
Cell therapy products differ from traditional small molecule or biologic drugs in product quality, preclinical testing, and clinical trial design. For example, in terms of product quality, Drug Substance testing may sometimes be exempted. Preclinical trials need to consider the existence of off-target toxicity. Clinical trial designs may require safety monitoring for up to a year. Moreover, these aspects often vary from product to product.
With professional consultants’ assistance, it is believed that your company can significantly reduce development time, costs, and risks.
Pantrone Consulting Co. Ltd. was established in 2019 and is a Contract Research Organization (CRO) specializing in cell therapy clinical trials. Pantrone is composed of a team of top-notch doctoral and master’s graduates from domestic and international universities.
Dr. Pan, the founder, graduated from the Department of Microbiology at National Taiwan University’s College of Medicine and EMBA from National Cheng-Chi University, and has over 15 years of experience in the biotechnology industry. His expertise includes the development of cell therapy products and small molecule drugs, as well as extensive experience in clinical trials, startups, and biotech investments. Our mission is to assist Taiwanese biotech companies in developing new drugs and accelerating their entry into clinical trials to save more lives.
