---
name: Proone Labs
slug: proonelabs
site: cro
website_domain: proonelabs.com
summary: Proone Labs provides preclinical pharmacology, drug discovery, and regulatory support services to biotech startups, traditional pharma, and in-silico companies. The team has delivered 30+ assays, 50+ cell lines, and supported 4 FDA drug approvals across multiple therapeutic areas.
tagline: Preclinical partner accelerating biotech from concept to regulatory readiness.
founded_year: 
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tier2_domain_verified: false
updated_at: 2026-10-12T07:01:46.575Z
services_count: 18
modalities_count: 4
indications_count: 3
locations_count: 0
review_signal_gate: closed
generated_by: BioBM Editorial AI
---

# Proone Labs

Preclinical partner accelerating biotech from concept to regulatory readiness.

Listed on cro.directory.

## Summary

Proone Labs provides preclinical pharmacology, drug discovery, and regulatory support services to biotech startups, traditional pharma, and in-silico companies. The team has delivered 30+ assays, 50+ cell lines, and supported 4 FDA drug approvals across multiple therapeutic areas.

## Services

- Discovery Research
- Target Identification & Validation
- High-Throughput Screening
- Medicinal Chemistry
- Computational & In-Silico Drug Discovery
- Protein Engineering
- Preclinical In Vitro Studies
- In Vitro Pharmacology
- In Vitro ADME / DMPK
- In Vivo PK / PD Studies
- In Vivo Efficacy Models
- Preclinical In Vivo Studies
- Bioanalysis
- Ligand-Binding Bioanalysis (Large Molecule)
- Analytical Method Development & Validation
- Regulatory Affairs
- US FDA Regulatory Strategy
- Translational Research

## Modalities

- Small Molecule
- Biologics (Monoclonal Antibodies)
- Antibody-Drug Conjugate (ADC)
- Cell Therapy

## Indications

- Neurology
- Gastroenterology
- Immunology

## Certifications

- GLP; Identifier: GLP-compliant; Source: https://proonelabs.com/

## Long description

## Overview

Proone Labs is a preclinical contract research organization serving the full spectrum of pharmaceutical and biotech clients—from early-stage startups and in-silico pharma companies to traditional and mid-sized pharmaceutical firms. Founded by experienced drug discovery scientists with a track record of FDA approvals and IND submissions, the company specializes in translating innovative concepts into regulatory-ready candidates.

## Core Services

**Preclinical Strategy & Execution**
- Expert strategic guidance for biotech innovators and established pharma
- Compound characterization and workflow integration
- Pharmacokinetics and pharmacodynamics (PK/PD) studies
- Small molecule TK (toxicokinetics) support

**Drug Discovery & Assay Development**
- High-throughput screening and target identification
- Assay development (30+ assays delivered)
- Cell line generation and reprogramming (50+ cell lines developed)
- CRISPR editing support
- Ligand binding assays (LBAs) for protein and anti-drug antibody quantitation
- Proteomics and metabolomics services

**Modality Support**
- Antibodies and antibody-drug conjugates (ADCs)
- Cell reprogramming and induced pluripotent stem cell (iPSC) generation
- Small molecule development

**Regulatory & Business Support**
- IND-enabling studies and regulatory compliance guidance
- Proof-of-concept and platform validation
- Due diligence and IP evaluation for investors
- Market analysis and go-to-market strategy development
- Risk assessment and partnership identification

## Quality & Compliance

- GLP-compliant operations with capacity for both GLP and non-GLP studies
- Stringent quality control on all data generation and reporting
- Collaborative, project-specific approach with close partner engagement

## Track Record

- 30+ assays developed for targets
- 50+ cell lines developed
- 5 FDA drug approvals (including Ozanimod for multiple sclerosis and ulcerative colitis)
- 15+ IND submissions supported
- 15+ analytical methods developed
- 4 successfully funded startups supported
- 10+ industry partnerships
- 5 disease areas served

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_Profile last updated: 2026-10-12T07:01:46.575Z. Profile facts may include AI-assisted enrichment._

Auto-generated by BioBM Editorial AI for machine-readable profile access.