Your Trusted Partner in Drug Development
Customized solutions for successful
non-clinical and clinical development —
delivered with precision and expertise
Projects Delivered
0+
PM Success Rate
0%
Global Partners
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Why LinkedBio?
We don't just manage — we partner. LinkedBio brings deep regulatory knowledge and hands-on project leadership to every stage of drug development.
Our PMs work from the sponsor's perspective — not as outsourced vendors — ensuring alignment with your goals at every step.
Every strategy is built around GCP compliance, MFDS/FDA requirements, and IND approval readiness from day one.
21 development projects completed, 9 IND approvals, and 100% PM deployment success rate across domestic and global clients.
From preclinical strategy through clinical trial operations to NDA/BLA — one partner for the full journey.
From preclinical research through pivotal trials — we provide sponsor-sided project management at every critical milestone.
Establish R&D direction, manage preclinical studies (efficacy, ADME, TOX), and align with regulatory requirements from the earliest stage.
Develop clinical trial synopsis, draft protocols, prepare IND packages, and coordinate regulatory submissions for MFDS/FDA approval.
Deploy sponsor-sided PMs to manage Phase 1 clinical operations, site selection, CRO oversight, and safety monitoring.
Manage dose-finding studies and efficacy evaluation with dedicated project management, ensuring protocol compliance and data integrity.
Full-scale clinical trial management through to NDA/BLA submission, with end-to-end operational oversight and regulatory coordination.
Track Record
Our team brings deep domain knowledge across a wide range of therapeutic areas, enabling precise strategy and execution tailored to each indication.
7
Solid tumors, hematologic malignancies, B-cell lymphoma
7
Alzheimer's, Huntington's, Multiple Neuropathy, ASD
4
Alopecia, acute bronchitis, digestive therapeutics
3
Surgical hemostasis, osteoarthritis, rheumatoid arthritis
9
Successful IND submissions and approvals
21
Non-clinical/clinical development projects
Stay Updated
LinkedBio Co., Ltd. and BioMarketing Lab have signed a mutual business agreement to provide high-quality, one-stop services for successful drug development and commercialization in the pharmaceutical and bio-healthcare sector.
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LinkedBio announces new strategic collaboration aimed at enhancing sponsor-sided project management services and IND-centered development strategies for pharmaceutical companies.
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EpiBioTek has signed an IND agreement with LinkedBio for its autologous cell therapy EPI-001 for alopecia, with LinkedBio providing full-scope consulting from clinical trial strategy to IND approval.
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