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 non-clinical research strategy through clinical trial operations to NDA/BLA — one partner for the full journey.
From non-clinical research through pivotal trials — we provide sponsor-sided project management at every critical milestone.
Establish R&D direction, manage non-clinical studies (efficacy, ADME, TOX), and align with regulatory requirements from the earliest stage.
We develop tailored clinical development plan strategies and protocols based on drug modality and target indications, prepare IND submission packages, and define regulatory strategies with gap remediation for MFDS/FDA approval.
To deliver safe, high-quality first-in-human trials, we assign sponsor-sided PMs to oversee trial operations, site selection, CRO management, and safety monitoring across the full program.
Experienced sponsor-sided project managers oversee dose-finding and mode-of-action proof studies, safeguarding efficacy assessment, safety outcomes, and data integrity.
We manage pivotal large-scale trials supporting marketing authorization (NDA/BLA), providing clinical trial management and regulatory engagement at the standard required for approval.
TRACK RECORD
Our team brings deep domain knowledge across a wide range of therapeutic areas, enabling precise strategy and execution tailored to each indication.
Stay Updated
LinkedBio (CEO Sungwoon Hong), a full-cycle new drug development PM (Project Manager) specialist, announced on June 1 that it is building a proprietary AI-based platform and expanding its expert workforce to mark its 5th anniversary.
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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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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. The partners will build cooperation across non-clinical, clinical, and commercialization stages and expand tailored sponsor support.
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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. LinkedBio will support development strategy, documentation, and regulatory responses with a focus on IND readiness and linkage to later clinical stages.
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