A Pre-IND meeting is a critical opportunity to confirm the regulatory authority’s perspective and identify potential approval risks in advance during the early stages of development. At C&R Research, we identify key questions to be addressed in meetings with regulatory bodies such as Korea’s MFDS, the U.S. FDA, and the European EMA, and develop a strategic question list from a multidisciplinary viewpoint in collaboration with clinical, non‑clinical, and CMC experts.

The pre-meeting package is organized to summarize development history and scientific rationale, presenting specific development plans for each area along with background explanations for anticipated issues. Following the meeting, we refine the development strategy based on the discussion outcomes and coordinate revisions to ensure that updates are incorporated into IND submission materials.

The Investigational New Drug Application (IND) document package is a core submission for obtaining clinical trial authorization and includes key components such as the clinical trial protocol, Investigator’s Brochure, non‑clinical study reports, and CMC documentation. We ensure the logical flow and scientific validity of the entire dossier by taking into account the interconnection of each section. When preparing IND documents, we review the consistency of data interpretation and compliance with regulatory guidelines, and enhance the completeness of the document through preliminary checks and professional reviews. In addition, we prepare anticipated Q&A responses to potential post‑submission queries from regulatory authorities, supporting an increased likelihood of approval.

The NDA (New Drug Application) stage involves comprehensively reporting the results of the entire development process to regulatory agencies, and is a critical process that determines whether a product will be commercialized. Through pre-NDA meetings prior to NDA submission, we review approval strategies, share data preparation status with regulatory agencies, and preemptively review technical or scientific issues that may arise at the time of submission.

During the review process, we respond to regulatory queries, such as Requests for Information or Complete Response Letters, by analyzing the authority’s evaluation focus points and preparing highly reliable data supported by sound scientific rationale and interpretation. This approach minimizes approval delays, improves review efficiency, and optimizes the overall product development timeline.