REGULATORY CONSULTING AND STRATEGY SERVICES
Build strategies that meet the demands of a dynamic regulatory environment in global and local
OUR VISION
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.
OUR MISSION
To structure one-way total solution for meeting global clients' needs in healthcare industry by 2020
VISION AND
MISSION
BUSINESS
AREAS
Regulatory Affairs
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.
Clinical Trials
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.
rPMS/Observational Study
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
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.
ICC (In-Country Caretaker)
MediHelpLine obtains and holds Import Licenses for products as directed by client and act as client’s representatives in relation to the Import Licenses in Korea.
New Business Development
MediHelpLine has plans on expanding its all business to global market and organizing a consortium by early 2017.
CONTACT
US
OUR ADDRESS
1009, 1014, Shinil Building, 131 Toegye-ro, Jung-gu, Seoul, 04537, Korea.
Email:
Tel: 02-6966-4100
Fax: 02-6966-4123
For any general inquiries and quotation, please fill in the following contact form: