Regulatory Affairs

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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

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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)

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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

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