meditip

Expanded full-cycle services for medical device regulatory approval and clinical trials through the acquisition of Promedis

Expansion of Meditip's SMO business

Expansion and reorganization of the Health Functional Food Division

Completed a total service platform providing regulatory approval, clinical, and global market entry through Dream CIS's acquisition of Meditip shares

Tigermed Family company

Meditip signed an MOU with EMMES, a U.S. cell therapy specialist CRO (joint work on FDA IND)

Meditip signed an MOU with PharmaLex, a U.S./Canada RA CRO (joint work on FDA IND)

Conducted the first-half 2020 IP-R&D strategy support project (approval-patent linkage) for the Korea Institute of Patent Information

Conducted the 2020 health industry commercialization (productization-regulatory approval) consulting support project for the Korea Health Industry Development Institute

Meditip signed an MOU with Dream CIS

Meditip signed an MOU with clinical CRO Dream CIS (a Tigermed subsidiary) and a global market entry agreement including China

Established Medical Device Global Registration Core Documentation (FDA, CE, PMDA, Singapore)

Participated in the innovative new drug pipeline discovery project of the Ministry of Science and ICT (consulting, monitoring, IND Filing)

Registered a patent for a wound dressing using biopolymer (U.S., China)

Conducted a research study on Southeast Asian GMP for the Ministry of Food and Drug Safety (MFDS)

Established the SOP for U.S. FDA Phase Pre-IND meetings

Established the SOP for medical device CE approval and ISO 13485 approval

U.S. FDA Phase II IND approval (Biologics)

Meditip signed a clinical trial outsourcing MOU with Cellgentech

Obtained medical device manufacturing KGMP

Company expansion and relocation (10th Floor, Seoul Gangnam Post Office Building, 619 Gaepo-ro, Gangnam-gu, Seoul)

Established the SOP for medical device CE approval and ISO 13485 approval

Participated in a pharmaceutical policy research project of the Ministry of Food and Drug Safety (MFDS) (medical products for human hazards)

Selected for the Ministry of Trade, Industry and Energy's CRO project in the medical-bio field (regulatory approval support for global market entry)

Signed an MOU with ProductLife Group S.A. (Global CRO) in Paris

Signed an MOU with POC Clinical Research Inc. (Japan CRO) in Japan

Signed an MOU with Evaluate Pharma (Database service)

Selected as a specialized CRO for global advanced biopharmaceutical regulatory approval strategy

Selected for the Ministry of Trade, Industry and Energy's overseas export consulting project in the medical-bio field

Established an office at the Korea Medi Venture Center within the Daegu-Gyeongbuk Advanced Medical Complex (DGMIF) and signed an MOU

Selected as a specialized CRO for building a new drug development database by the Osong Medical Innovation Foundation

Selected as a specialized CRO for new drug development monitoring by the Daegu-Gyeongbuk Medical Innovation Foundation

Signed an MOU with Woodley BioReg Ltd. in the U.K.

Signed an MOU with PharmEng Regulatory Affairs Asia in the Asia-Pacific region

Established an office at the Venture Center of the Chungbuk Osong Industry-Academia Convergence District

Ministry of Health and Welfare, pharmaceutical industry consulting support

Signed an MOU with the Chungnam National University Hospital Clinical Trial Center and CNR Research

Ministry of Food and Drug Safety (MFDS), support for developing training materials for the medical device RA specialist program

Signed an MOU with the Osong Medical Innovation Foundation

Company expansion and relocation (SH Corporation Building)

Signed an MOU with NovoTek in China

Ministry of Trade, Industry and Energy, new drug development regulatory approval consulting support for the Chungcheong Regional Leading Industry Support Group (~2015)

Launched Product license maintenance (local agent for foreign companies) service

Signed an MOU with Clinivation, Inc. in the U.S.

Participated as the Korean representative in a healthcare industry exhibition at the invitation of the Danish Embassy

April: Meditip Co., Ltd. established (consulting for pharmaceutical and medical device product approval and insurance listing)