Regulatory Consulting

About Service

DreamCIS offers the consulting service to optimize the regulatory pathway to maximize the values of all products across drug R&D.

The consulting service team of DreamCIS consists of professionals with many experiences in various fields from the early clinical development to the new drug application and a high level of understanding into the applicable regulations so that the team can help clients set up the approval strategies that meet the needs for the investigational new drug approval and the new drug application.

Service Scope

Regulatory strategy

• Clinical development strategy
• Regulatory gap analysis
• MFDS meeting preparation and attendance

IND/NDA Submission support

• Initial/amendment submission package preparation
• Amendment submission package preparation
• follow-up with MFDS after submission
• IND holder service

Post Approval support

• Regulatory reporting (annual report, FPI report, LPO report, etc.)
• Import license for non IP
• IP labeling

Service Process