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Accelerate Drug Discovery with
Expert Assay Development & Validation

Reliable, reproducible assays tailored for startups, biotech innovators, and pharma leaders.

Introduction

Developing new compounds requires accurate, high-quality 
data. Assay development and validation are critical steps in 
drug discovery, ensuring your results are robust, reproducible, 
and regulatory-compliant. Whether you’re a startup seeking 
cost-effective solutions or a pharma company scaling complex workflows, we provide the expertise to move your science forward.

What is Assay Development?

Assay development is the process of designing and optimising tests that measure biological activity, compound potency, or target engagement. A well-developed assay provides the foundation for screening, lead optimisation, and decision-making throughout the drug development pipeline.

Why Validation Matters

Validation confirms that your assay performs consistently and accurately under defined conditions. It reduces risk, supports your discovery and development goals, and progresses through regulatory submissions, ensuring confidence in your data.

Our validation protocols align with FDA and EMA guidelines, providing high quality, reproducible data throughout all clinical phases , allowing your teams to continue with data analysis progressing your clinical trial.

Our Expertise

Assay Formats

Cell-based, Immunology, Serology, Enzyme, ELISA, Multiplexed binding, Molecular Biology, Drug Potency

Platforms

ELISA, MSD, ELISpot, ddPCR QX700, Multiplex Cytokine Profiling MSD, NGS Illumina and DRAGEN pipeline, ddPCR, CTL Bacterial colony counter

Customisation

Tailored solutions for unique targets and modalities

Regulatory Alignment

GCLP, GLP-compliant, assays validated to ICH guidelines

Benefits for Startups, Biotech, and Pharma,

Startups

Cost-effective, rapid development to accelerate proof-of-concept

Biotech

Scalable biotech assay solutions for growing pipelines

Pharma

High-throughput, validated assays for global compliance

How hVIVO Can Solve Your Challenges

Our in-house team of cross-functional experts including consultancy, science, and laboratory operations will work with you on:

Consultation & Design aspects

Optimisation & Development

Validation & Documentation

Ongoing Support

If you’re a potential customer, job seeker, health professional or an investor, find out how hVIVO can help you.

Contact hVIVO

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