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Specialist expertise

Regulatory Support & IND Application

FDA regulatory consultation and IND application filing package preparation.

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The science

About this capability

Regulatory support for antibody drug discovery ensures compliance with FDA guidelines from target validation to IND submission. Key areas include establishing a Quality Target Product Profile (QTPP), characterizing monoclonal antibodies (mAbs) binding, assessing immunogenicity, and defining CMC compliance. Specialized support manages complex antibody-drug conjugates (ADCs) and bispecifics, optimizing dose-finding and clinical protocols.

Technical scope

  • Regulatory Consultation
  • Data Package Preparation
  • IND Application

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Strategic Consultation & Discovery Planning

Structured, multi-disciplinary approach to turn a therapeutic target into a viable clinical candidate through target validation and customized roadmap planning.

Target Identification & Therapeutic Candidate Screening

Identifying disease-associated molecules (proteins, receptors) and selecting high-affinity antibodies through in-vivo/in-vitro screening.

Chemistry: Lead Optimization & ADC Design

Iterative phases combining antibody engineering, linker chemistry, and cytotoxic payload selection to refine ADC structure for efficacy and safety.

Proof of Concept (POC) Studies

Early-stage preclinical assessments validating candidate antibody binding affinity, target specificity, functional efficacy, and stability.

In-Vitro & In-Vivo Validation

Transitioning candidates from initial binding screens to functional development via in-vitro bioassays and in-vivo tumor xenograft studies.

Preclinical Development

Optimizing lead antibodies through affinity maturation, humanization, and Fc engineering, and scaling up conjugation processes.

Let’s work together

The right expertise.
For your next step.

Talk with our scientific team about your requirements,
technical feasibility, and timelines.

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+1 604-339-3244

What happens next

  1. Share your requirementsTell us about your research goals, scope, and timelines.
  2. Scientific consultationOur scientists review feasibility and discuss the best approach with you.
  3. Proposal and quoteReceive a clear proposal covering scope, deliverables, timelines, and cost.