REGULATORY CONSULTING AND STRATEGY SERVICES
Build strategies that meet the demands of a dynamic regulatory environment in global and local
MediHelpLine Co., Ltd. contributes to
the development of the healthcare industry
by providing high quality services,
which come from our specialized knowledge and profound experiences.
We help our client in creating success and prosperity by expediting its product development and registration.
We strive unceasingly to be the unquestioned best partner with our customers in Korea.
To structure one-way total solution for meeting global clients' needs in healthcare industry by 2020
With knowledge of legal and regulatory affairs of medical devices, bio-pharmaceuticals, cosmetics and foods, MediHelpLine is in charge of licensing, production, and quality assurance and communicating with MFDS.
MediHelpLine has experiences in
Phase I ~ III and Phase IV trials in almost all therapeutic areas. It supports at every stage such as study designing, clinical operation, data management, statistical analysis and medical writing.
For observational studies like Post Marketing Surveillance(PMS), Non-Interventional Studies (NIS), Post-Authorization Safety Studies(PASS) or Post-NDA studies, MediHelpLine provides high-quality of comprehensive Electronic Data Capture (EDC) system which meets the relevant regulatory requirements.
R&D Center not only strengthens the current portfolio but searches for new drug which can provide a new opportunity to potential patients.
It also participates in the national research project on medical devices.
1009, 1014, Shinil Building, 131 Toegye-ro, Jung-gu, Seoul, 04537, Korea.
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