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Global  Healthcare  No.1

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 expeding 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 Corp. is in charge of licensing, production, and quality assurance and communicating with MFDS. 

Clinical Trials

 

MediHelpLine Corp. 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-Authorisation 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 Corp. 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 Corp. has plans on expanding its all business to global market and organizing a consortium by early 2017.

CONTACT

US

OUR ADDRESS

1014, Shinil Building, 131 Toegye-ro, Jung-gu, Seoul, 04537, Korea. 

Email: mhl@medihelpline.net
Tel:  02-6966-4100

Fax: 02-6966-4123

 

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