We provide expert regulatory strategy tailored to the complex domestic and international requirements at each stage of clinical development (from preclinical studies to Phase 1, 2, and 3 trials, and Real-World Evidence (RWE) studies). From preclinical research, the first stage of new drug development, to phase 1, when the drug is first administered to humans, to phases 2 and 3, when efficacy and safety are confirmed, to real-world trials, we provide support to meet the complex domestic and international regulatory requirements for each stage.

Leveraging a regulatory science–driven approach, we conduct a comprehensive review of the entire documentation flow, including clinical trial protocols, investigator brochures, CMC data, and non-clinical materials, while designing stage-specific submission strategies and timelines. We provide comprehensive support covering preparation for preliminary meetings with national regulatory authorities, development of Q&A response strategies, document review, and communications, thereby minimizing regulatory risks throughout the development process and maximizing the likelihood of successful approval.

Pharmaceutical development must meet differing regulatory requirements in each country, and approval strategies must be optimized for local regulatory environments. Based on guidelines from key regulatory agencies including Korea's MFDS, the U.S. FDA, and the European EMA, we compare and analyze country-specific requirements and propose customized strategies tailored to each stage of development. In the early development phase, pre-IND or pre-consultation meetings are conducted to identify necessary requirements, strengthening the scientific rationale of development data and enhancing the probability of regulatory approval.

We provide integrated execution support throughout the entire process, including document preparation, schedule coordination, and response strategies tailored to each approval stage, such as IND (Investigational New Drug) and NDA (New Drug Applications). This strategic approach minimizes unnecessary delays and additional requests from regulatory agencies, enabling efficient approval.

To ensure the successful conduct and approval of clinical trials, we manage smooth and professional communication with regulatory authorities while providing in-depth medical consultation. We conduct medical reviews of submission materials required for clinical trial approval, carefully verifying that all documents such as protocols, investigator brochures, and informed consent forms are aligned with the latest medical knowledge, regulatory requirements, and both scientific and ethical soundness. Materials are prepared in accordance with the rigorous standards set by regulatory bodies, while logical justifications are developed to address potential medical or scientific questions. We actively participate in regulatory agency meetings to provide expert medical advice, supporting clinical trials in meeting regulatory requirements and achieving successful approval.