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KOREN

SERVICES

Integrated Development Services

From non-clinical science through IND, clinical trials, and approval — strategy and execution aligned from the sponsor’s perspective.

What We Offer

Three Core Practices

Full-cycle drug and biotech development

Full-Cycle Development

Full-Cycle Drug & Biotech Development

Sponsor-sided PM across non-clinical strategy, IND, Phases 1–3, and NDA/BLA readiness — one connected thread from lab to filing.

  • Continuity from non-clinical to clinical strategy
  • IND documentation and supplement response
  • CRO/vendor oversight tied to approval strategy
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IND strategy and approval readiness

IND Strategy

IND Strategy & Approval Readiness

From non-clinical GAP analysis through filing strategy and authority dialogue — integrated IND design focused on approvability.

  • Clinical-linked non-clinical GAP analysis
  • IB, protocol, and submission package readiness
  • Regulatory (RA) alignment and deficiency response
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Sponsor-sided clinical trial project management

Clinical PM

Sponsor-Sided Clinical Trial PM

After IND, delegated sponsor R&R for timeline, quality, and risk — execution-led PM through study close and inspection readiness.

  • Full-lifecycle PM and decision support
  • CRO oversight and proactive issue management
  • Inspection readiness and regulatory support
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