With knowledge of legal and regulatory affairs of medical devices, Bio-pharmaceuticals, cosmetics, and foods, Medi Help Line is in charge of licensing, production, and quality assurance and communicating with MFDS.
For observational studies like Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS), Post-Authorisation Safety Studies (PASS) or Post-NDA studies, Medi Help Line provides high-quality of comprehensive electronic data capture (EDC) system which meets the relevant regulatory requirements.
Medi Help Line 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.
Medi Help Line 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.
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.
Medi Help Line has plans on expanding its all business to global market and organizing a consortium by early 2017.