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Regulatory Affairs (Drug)

About service

C&R Research has expanded its regulatory affairs services to include all phases of clinical drug development, ranging from early pre-IND (Investigation New Drug) application stage to final approval by Ministry of Food and Drug Safety (MFDS). We carefully suggest all of efficient strategies and alternatives during each step of the regulatory process towards successful product approval. Our regulatory affairs team is composed of professionals who have extensive experience and expertise in various clinical fields and help clients register product without costly delays.

Package Preparation & Submission to MFDS

Follow Up after MFDS Submission

Pre-IND meeting

Guidance on strategic direction

C&R Research’s professionals offer high-level regulatory strategies to expedite the whole clinical drug development process from pre-IND stage to MFDS’s approval, as part of efforts to expedite products through clinical trials and into the market. When necessary, our consulting services are provided for MFDS meeting and preparation of non-clinical data or Medical Writing (protocol, etc.). They are always flexible and responsive to MFDS’s questions and provide strategic opinions that may eventually lead to MFDS’s approval.

Vast experience and expertise in regulatory affairs service

C&R Research employs a great number of experts with master’s and doctorate degrees. Their extensive experience in regulatory affairs at home and abroad helps clients prepare registration dossier for MFDS’s approval. Our professionals’ vast experience extends from Phased 1 clinical trial (pharmacological study) to pivotal study for regulatory approval, as well as experience with a variety of compound types (biologics, radiological drugs, etc.). Further, C&R Research’s experts have extensive backgrounds across a broad range of therapeutic areas including Oncology, so they can suggest more specialized opinions. Reliable consulting services are also available through medical advisors.

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