Dt&CRO and Radyus Research introduce '바카라 에볼루션 toxicity test consulting' service
Created by experts with in-depth knowledge of 바카라 에볼루션 requirements and guidelines
[by Yu, Suin] Dt&CRO, a contract research organization (CRO) specializing in non-clinical and clinical trials, announced on April 14 that it will officially launch a U.S. Food and Drug Administration (바카라 에볼루션) toxicity testing consulting service this month. This initiative will be carried out in collaboration with Radyus Research, a U.S. new drug development consulting firm.
This collaboration forms part of a strategy to support 바카라 에볼루션 approval, and the company anticipates that it will offer more practical assistance to Korean pharmaceutical and biotechnology firms seeking entry into the U.S. market by directly delivering strategic consulting services for toxicity testing to Korean clients.
The newly introduced services include 바카라 에볼루션 Toxicology Study Review (FTSR), targeting toxicity test data, and 바카라 에볼루션 Toxicology Study Consulting (FTSC). In particular, FTSC provides tailored research protocol design and strategic planning from the early stages of toxicity test preparation, ensuring alignment with the requirements of the 바카라 에볼루션 and other global regulatory authorities. This approach is expected to enhance the likelihood of regulatory approval and promote efficient development processes.
According to Dt&CRO, the core strength of this service lies in that experts with a deep understanding of the standards and strategic direction required by the 바카라 에볼루션 actively lead the design of toxicity studies rather than merely reviewing test data. Drawing on the extensive experience collaborating with the 바카라 에볼루션 and other global regulatory bodies, the service offers ‘practical consulting’ that optimizes toxicity study design, from the strategic planning and data utilization methods to detailed protocol specifications, in a way that maximizes the possibility of 바카라 에볼루션 approval.
Anthony Chilton, Chief Operating Officer (COO) of Radyus Research, brings over 30 years of expertise in toxicology and pharmacokinetics (PK), having led global non-clinical development projects at major pharmaceutical companies including GlaxoSmithKline (GSK), Roivant, and Inotiv. Dr. Dave Edwards, a seasoned expert with more than 40 years of experience in novel drug development, has overseen toxicology research and first-in-human new drug development strategies in various therapeutic areas, including cardiovascular, central nervous system (CNS) disorders, and oncology. Both Chilton and Edwards will serve as key advisors for the FTSC service.
Through this collaboration, Dt&CRO and Radyus Research have established a dual-integrated system that addresses language and communication barriers often encountered by domestic clients, allowing them to conduct toxicity studies directly in Korea while receiving consulting based on U.S. regulatory standards. Dt&CRO emphasizes that its in-depth understanding of Korean clients’ data quality, organizational structures, and communication practices is a major strength in tailoring effective consulting strategies.
“By leveraging Radyus Research’s extensive global network, we are able to comprehensively incorporate strategies for pharmaceutical quality control (CMC), regulatory affairs (RA), clinical development, analytical research, and quality assurance into our test design and analysis,” a Dt&CRO official said. “Each project is assigned a dedicated lead who oversees the project closely, functioning as an extension of the client’s internal team.”
In particular, the company highlighted that the toxicity test consulting offered through this collaboration goes beyond conventional advisory services, focusing instead on ‘practical analysis’ and ‘strategic design’ tailored specifically for 바카라 에볼루션 submission. By combining Radyus Research’s extensive experience in 바카라 에볼루션 communication and approval with Dt&CRO’s test execution capabilities, bolstered by its Good Laboratory Practice (GLP) certification, the partnership aims to simultaneously ensure the scientific quality and regulatory strategy design to optimize toxicity testing for successful U.S. approval.
"This consulting service is an advanced solution that supports the formulation and execution of strategies considering the entire novel drug development cycle," the official further added. "We expect it will serve as a valuable tool to help Korean pharmaceutical and biotech companies navigate through the gateway called '바카라 에볼루션 approval' more quickly and efficiently."