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.
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.
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.
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.