Created by experts with in-depth knowledge of 슬롯사이트 추천 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 (슬롯사이트 추천) 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 슬롯사이트 추천 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 슬롯사이트 추천 Toxicology Study Review (FTSR), targeting toxicity test data, and 슬롯사이트 추천 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 슬롯사이트 추천 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 슬롯사이트 추천 actively lead the design of toxicity studies rather than merely reviewing test data. Drawing on the extensive experience collaborating with the 슬롯사이트 추천 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 슬롯사이트 추천 approval.
Anthony Chilton, Chief Operating Officer (COO) of Radyus 슬롯사이트 추천, 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 슬롯사이트 추천 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 슬롯사이트 추천 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 슬롯사이트 추천 strategies.
“By leveraging Radyus 슬롯사이트 추천’s extensive global network, we are able to comprehensively incorporate strategies for pharmaceutical quality control (CMC), regulatory affairs (RA), clinical development, analytical 슬롯사이트 추천, 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 슬롯사이트 추천 submission. By combining Radyus Research’s extensive experience in 슬롯사이트 추천 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 '슬롯사이트 추천 approval' more quickly and efficiently."