Common Technical Document (CTD)
The Common Technical Document (CTD) is a standard format for presenting data in an Investigational New Drug (IND) application to the FDA, ensuring consistent and comprehensive information for regulatory review.
The CTD consists of quality, nonclinical and clinical attributes of required IND documentation.
CTD Triangle
What is the CTD Triangle? The Common Technical Document (CTD) can be represented by a visual triangle or "pyramid" of the required documents which must be organized and complete before submitting a new investigational drug (IND) application to the FDA.
Module 1, at the peak of the pyramid, contains regional administrative information.
Module 2, mid-tier in the pyramid, focuses on summaries such as quality, nonclinical and clinical information for the investigational new drug (IND).
Module 3, at the base of the pyramid, contains the details of quality, nonclinical and clinical information.
BioDuro-Sundia CTD and IND Services
Our dedicated regulatory team provides comprehensive services including the CTD in full support of our clients' IND applications to the FDA, NMPA, and other respected regulatory agencies with bilingual translation available.
We support all aspects client IND applications, including dossier, data and communication. In addition to the complete Common Technical Cocument (CTD) management, BioDuro-Sundia performs a comprehensive range of preclinical in vitro and in vivo studies needed to prepare for an IND application.
Learn more about our IND Enabling platform.FAQ: IND Filing and Documentation Services
Q: Does BioDuro-Sundia have a regulatory team capable providing support and communication with the FDA?
A: Yes, our dedicated regulatory team located in China frequently contacts the FDA on behalf of clients with IND applications in progress. Our experts have several years of experience communicating directly with the FDA to submit and support various clients’ IND applications.
Q: To what extent does BioDuro-Sundia put the IND application materials together, for example, can your CRDMO submit INDs to both the US and China regulatory agencies?
A: Yes, our regulatory team can prepare complete IND application materials on behalf of clients, from both the scientific and the regulatory perspectives. In addition to preclinical CMC services, we also offer DMPK, toxicology, and bioanalysis services preceding IND submission. Although most of our clients file with the FDA only, we often translate a new drug’s documentation into both English and Chinese languages for submission with both the US FDA and China NMPA.
Q: Can BioDuro-Sundia support CMC and IND activities in-house?
A: Yes, our preclinical CMC and IND enabling activities are done in-house, and in certain cases all at one facility. Our integrated approach connects all required services leading to IND submission, including scale-up of specialized chemistries, DMPK and biological data collection, extending to pilot-scale and kilo-scale production of drug substances and drug products.
Q: Where is BioDuro-Sundia solid-state characterization work done?
A: We select the most appropriate facility to perform solid state characterization based on client needs. Typically, preformulation work takes place in our Jiangsu Site and process R&D work takes place in our Shangai-Waigaoqiao Site.
Q: Can you offer an example of a recent successful IND program at BioDuro-Sundia?
A: Yes, we continually improve our IND enabling services meet client demand and regulatory compliance. Furthermore, our IND-related services cover both drug substances and drug products. Recently, we supported a client whose IND program involved a complex 8-step process for which our team completed both R&D activities and the IND documents in 11 months' time.
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