The Investigator’s Brochure (IB) is a core document providing researchers with comprehensive clinical and non-clinical information about the investigational product, necessitating inclusion of the most up-to-date data. It supports researchers in clear understanding of the clinical trial by integratively describing the drug’s mechanism of action, efficacy, and safety data from a clinical perspective. Key data such as non-clinical toxicology results, pharmacokinetics, and prior clinical trial outcomes are carefully compiled to enhance overall document completeness. During the annual update process, latest literature and clinical trial data are thoroughly reviewed and analyzed to identify significant changes, ensuring the IB is revised to meet Institutional Review Board (IRB)/Independent Ethics Committee (IEC) review and regulatory authority assessment requirements.

The Investigational Medicinal Product Dossier (IMPD) and Investigational New Drug Application (IND) are core documents for initial approval, where the overall credibility of the dossier depends on meeting regulatory requirements across the quality, non-clinical, and clinical sections. We conduct thorough analyses of international standards such as ICH guidelines M4, M3, M2, and systematically structure the essential information required in each module.

Since the IMPD and IND are compiled from a wide range of original source materials, they must be written to avoid discrepancies or redundancies and align with the review perspective of regulatory authorities. At C&R Research, we maintain document consistency through systematic cross‑referencing. Recognizing that the scope of permissible data varies by stage of drug development, we establish writing strategies that distinguish between requirements for, for example, Phase 1 and Phase 3 trials or pre-approval submissions. We also manage approval timelines efficiently by aligning documentation plans with each client’s development schedule.

The Common Technical Document (CTD) is an international standard format for global regulatory submissions for products such as pharmaceuticals and medical devices. It is structured around key reviewer focus points to streamline the complex regulatory approval process and support simultaneous or sequential market entry across multiple countries.

We provide professional document preparation support by identifying and applying the latest guidelines and requirements of major regulatory agencies in countries and regions such as the Korean MFDS, US FDA, and European EMA. By providing the information required by each regulatory agency in a consistent format through the CTD, we can significantly reduce time and costs and increase efficiency.