IND-Enabling Studies Support

Advance candidates into the clinic with confidence and comprehensive data packages.

Key Capabilities

Biologics: Functional characterization, PK/PD studies via partners, and batch-scale protein supply
Protein Science: GMP-adjacent production of tool and reagent proteins for IND-enabling assays
Strategic Consulting: IND planning, regulatory guidance, and market-positioning strategy
Data Science: Clean, auditable, traceable datasets supporting regulatory submissions
Structural Biology: Confirmation of target engagement and structural rationale for candidate selection

Value to Your Program

Streamlined transition from discovery to development
Structured data that meets regulatory and audit requirements
Flexible and scalable assay support for preclinical decision-making
Strategic guidance to support partnering, funding, and clinical milestones

Validation Metrics

Guided 12+ biologics into IND with comprehensive data support
Produced GMP-grade proteins with consistent QC metrics across batches
Supported clients reducing preclinical readiness timelines by up to 35%
Enabled successful IND filings and Series A/B raises via data-driven strategic positioning