Dt&CRO

What Dt&CRO does

Dt&CRO (주식회사 디티앤씨알오, KOSDAQ ticker 238490) is Korea's first and only full-service Contract Research Organization, providing end-to-end drug-development services spanning nonclinical GLP toxicity testing, PK/PD analysis, efficacy evaluation, bioanalysis, bioequivalence, Phase 1–3 clinical trials, and FDA/EMA regulatory consulting. Founded in 2017 and listed on KOSDAQ in November 2022, the company operates four integrated research divisions — the Safety Evaluation Center, Efficacy Evaluation Center, BioAnalysis Center (all in Yongin-si), and the Clinical Trial Business division in Seoul — supported by proprietary technology including an in-house SEND (Standard for Exchange of Nonclinical Data) program that was the first domestically developed in Korea, a Laboratory Information Management System (LIMS) with native SEND connectivity, and the MoPS project-scheduling platform. Certifications and designations are unusually dense: GLP (2020), MFDS nonclinical/medical device/clinical specimen/bioequivalence testing designations, chemical and agricultural substance testing, ISO 14155 (first Korean CRO), CDISC SEND-standard partnership, and AAALAC accreditation.

Dt&CRO serves pharmaceutical, biotech, medical device, chemical, health-functional-food, and cosmetics sponsors across Korea, Japan, Australia, Vietnam, and the US through direct enterprise sales and partnerships (Radyus Research for FDA consulting, AVANCE Clinical in Australia, IDD in Japan). Revenue is generated on a project-based professional services model with quote-based contracts; revenue grew from KRW 35.97 billion in 2024 to KRW 47.7 billion in 2025 (~33% YoY), while operating losses narrowed from KRW 11.3B to KRW 5.7B, with a 200 billion KRW investment from Eugene Private Equity in March 2026 explicitly earmarked to accelerate the path to profitability and global CRO expansion. Differentiated outcomes include an 80% bioequivalence success rate across 140 of 177 cases and preclinical orders doubling within a single year.

Name

Dt&CRO

Legal name

주식회사 디티앤씨알오

Website

https://dtncro.com

Company type

Public

Founded year

2017

Operating status

Operating

Headcount range

101–250 employees

Short description

Dt&CRO is Korea's only full-service CRO providing integrated nonclinical GLP, PK/PD, efficacy, bioanalysis, and Phase 1–3 clinical trial services to pharmaceutical, biotech, medical device, chemical, health food, and cosmetics sponsors across Asia-Pacific and the US.

Ownership category

akta.pro rank

Product category

Contract Research Organization (CRO) Services

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714), Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC), Bioanalytical & Biomarker CROs (PK/PD/Immunogenicity) (HLAGAAAD), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Contract research services
• Preclinical GLP studies
• Clinical trial management
• Bioanalytical services
• FDA regulatory consulting

Headquarters

HQ city

Seoul

HQ country

South Korea

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Infrastructure, Technology or R&D, Marketing or Sales

Revenue model

1. Preclinical Services: Nonclinical GLP toxicity testing, PK/PD studies, safety pharmacology, genotoxicity, and specialized studies for pharmaceuticals, chemicals, medical devices, health functional foods, and cosmetics.
2. Efficacy Evaluation Services: Efficacy evaluation studies for drug candidates, including disease animal models, oncology studies, biodistribution studies, and PK/PD testing for small to large animals.
3. Bioanalysis Services: Clinical sample analysis, animal sample analysis (TK/PK), protein characterization, in vitro ADME, ADA analysis, and bioequivalence testing.
4. Clinical Trial Services: Phase 1-3 clinical trials for pharmaceuticals, medical devices, and health functional foods, including regulatory affairs, data management, biostatistics, pharmacovigilance, and quality assurance.
5. FDA Regulatory Consulting: IND/NDA consultation, FDA submission support, and SEND data preparation services through Radyus Research partnership.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels4 records

Core offering

Dt&CRO is Korea's first and only full-service Contract Research Organization (CRO) providing integrated services spanning the entire drug and product development lifecycle — from nonclinical GLP toxicity, safety pharmacology, PK/PD, and efficacy evaluation through bioanalysis, bioequivalence, and Phase 1-3 clinical trials, plus regulatory consulting for FDA IND/NDA and MFDS approvals. The company serves pharmaceutical, biotech, medical device, chemical, health functional food, and cosmetics clients, supported by in-house proprietary SEND, LIMS, and MoPS platforms and a partnership with US-based Radyus Research for FDA submissions.

Product overview

Dt&CRO is Korea's first and only full-service CRO offering integrated, one-stop research services spanning the entire drug development lifecycle from nonclinical GLP toxicity, PK, and efficacy testing through bioanalysis, bioequivalence studies, clinical trials, and regulatory consulting. The company serves pharmaceuticals, chemicals, health functional foods, cosmetics, and medical devices. Its portfolio consists of four core research divisions — the Safety Evaluation Center (nonclinical GLP studies), Efficacy Evaluation Center (efficacy testing), Bioanalysis Center (bioanalytical services), and Clinical Trial Business (clinical operations) — supported by specialized services including the FDA Full Package Service (GLP + IND/NDA consulting via Radyus Research partnership), SEND Service (FDA-compliant data conversion), and a proprietary LIMS platform that synchronizes study data directly to SEND format. Together, these form a complete preclinical-to-clinical value chain under one organization.

Differentiator

Problem solved

Functional benefit

Products and services

• Safety Evaluation Center (안전성평가센터) — Nonclinical GLP Safety Testing GLP-certified nonclinical safety studies including general toxicity, genotoxicity, local/immunotoxicity, reproductive/developmental toxicity, safety pharmacology, and ecotoxicology tests for pharmaceuticals, chemicals, health functional foods, cosmetics, and medical devices.
• Efficacy Evaluation Center (효능평가센터) — Efficacy (Validity) Evaluation Efficacy (validity) evaluation studies using scientific and rational methodologies for drug candidates, health functional products, and cosmetics, covering therapeutic areas including oncology, metabolic diseases, neurological disorders, biodistribution studies, and PK/PD testing for small to large animals.
• Bioanalysis Center (분석센터) — Bioanalytical Services Bioanalytical services including clinical sample analysis, animal sample TK/PK analysis, protein characterization and quantification (peptide mapping, PTM check, de novo sequencing, intact mass, disulfide bond), GLP analysis, bioequivalence sample analysis, ADA analysis, and in vitro ADME studies using advanced LC-MS/MS instrumentation (Triple Quad 7500).
• Clinical Trial Business (임상사업부) — Phase 1-3 Clinical Trials Full-scope clinical trial services including product development consulting, regulatory affairs, Phase 1-3 clinical trials for pharmaceuticals/medical devices/health functional foods, post-approval trials, pharmacovigilance, data management, biostatistics, and quality management. First domestic CRO to obtain ISO 14155 certification for medical device clinical trials.
• FDA Full Package Service (FDA IND/NDA Full Package) End-to-end support for FDA IND and NDA approvals through GLP-certified studies conducted at Dt&CRO facilities and strategic consultation and application support provided by partner Radyus Research, covering all stages from preclinical testing to FDA submission.
• SEND Service — FDA SEND Data Conversion Conversion of nonclinical study data to FDA-required SENDIG v3.1 format for eCTD submissions. The company was the first Korean organization to develop an in-house SEND program and can convert legacy data from other testing facilities using its proprietary conversion software.
• Pharmaceutical GLP Study Service GLP-certified nonclinical toxicity testing service for pharmaceutical drug substances, providing general toxicity, safety pharmacology, and PK studies to support regulatory submissions.
• Chemicals and Pesticides GLP Testing Service GLP-certified toxicity testing service for chemical substances and pesticides under the Chemical Registration and Evaluation Act, supporting environmental regulatory compliance filings.
• Medical Device GLP Testing Service GLP-certified nonclinical testing for medical devices, including safety evaluation studies to support regulatory submissions and CE MDR certification pathways.
• PK/PD Center — Pharmacokinetics/Pharmacodynamics Analysis Pharmacokinetics and pharmacodynamics analysis center providing PK/PD testing services for drug development, supporting small to large animal studies and integrated bioanalytical workflows.
• Protein Characteristics Analysis Service Protein characterization service for biopharmaceuticals including peptide mapping, post-translational modification (PTM) check, de novo sequencing, intact mass analysis, and disulfide bond analysis. Approximately 80 bioequivalence analyses conducted annually.

Quantifiable outcome

• 80% bioequivalence success rate with 140 equivalent cases out of 177 studies performed
• +3 more outcomes

Named customers6 records

Segments5 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration6 records

Feature5 records

Partnerships

15 partnerships are on record, tiered core and minor.

• BioVits (바이오바이츠)coreStrategic or Co-development Partner · 1 March 2026Partnership for sarcopenia new drug development covering full preclinical to clinical cycle. Dt&CRO provides comprehensive nonclinical and clinical services for BioVits' drug candidate development.
• IDD (Japan)coreChannel Partner/ Reseller/ Distributor · 27 October 2025Strategic business agreement signed October 2025 with Japanese CRO specialist company IDD, enabling expanded service coverage in Japanese market and cross-border clinical trial capabilities.
• KoNECTminorOthers · 25 September 2025Participation in KoNECT International Conference as part of efforts to showcase integrated bio service platform and promote company capabilities to international audience.
• BIX 2025minorOthers · 22 September 2025Participation in BIX 2025 conference to showcase integrated R&D capabilities and global expansion strategy.
• LuDACurecoreStrategic or Co-development Partner · 25 August 2025Partnership combining Dt&CRO's CRO capabilities with LuDACure's new drug screening technology to accelerate drug development timelines through integrated preclinical services.
• Design by J (디자인바이제이)minorStrategic or Co-development Partner · 11 August 2025Huscience (Dt&CRO Bio Group subsidiary) partnered with Design by J to develop clinical research service models for enhanced clinical trial operations.
• Ajou UniversityminorStrategic or Co-development Partner · 11 July 2025Partnership for efficacy evaluation of mental and behavioral disorders, combining academic research expertise with CRO service capabilities.
• SPMed (에스피메드)minorStrategic or Co-development Partner · 29 April 2025Technical education and research cooperation partnership for enhanced expertise sharing in preclinical and clinical research.
• Port NovaminorStrategic or Co-development Partner · 24 February 2025Huscience (Dt&CRO Bio Group subsidiary) strategic partnership for clinical specimen analysis services, expanding analytical capabilities through specialized expertise.
• Eumsci (애임스바이오사이언스)coreStrategic or Co-development Partner · 21 February 2025Comprehensive collaboration for new drug R&D and clinical trials, covering the full development cycle from research to clinical stages.
• AstroZenecacoreStrategic or Co-development Partner · 13 January 2025Partnership for new drug development and preclinical cooperation, leveraging combined capabilities for accelerated development programs.
• NS Bio (엔이에스바이오)minorStrategic or Co-development Partner · 5 December 2024Joint research initiation for mRNA vaccine toxicity evaluation, combining expertise in novel vaccine development and GLP toxicology testing.
• Radyus ResearchcoreStrategic or Co-development Partner · 15 March 2024Dt&CRO and Radyus Research signed an MOU on March 15, 2024, providing comprehensive services from nonclinical GLP tests through IND/NDA approval consulting and FDA submission support. Radyus Research provides strategic analysis and consulting services for FDA and EMA clinical trial approvals through personnel with pharmaceutical company and academic networks.
• Korea University Medical CenterminorStrategic or Co-development Partner · 1 November 2023Clinical trial education contract signed November 2023 for training and academic cooperation in clinical research.
• AVANCE CLINICALminorStrategic or Co-development Partner · 1 June 2023MOU signed June 2023 for clinical trial cooperation, expanding Dt&CRO's global reach and capabilities in international clinical research.

Scale indicators6 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• IQVIA: World's largest CRO with biotech-focused services, real-world data, and global clinical operations; competes with Dt&CRO for international biotech sponsors and Korean multinational trial work.
• Wuxi AppTec: Asia's largest full-service CRO spanning preclinical through clinical and CDMO; competes with Dt&CRO across the same one-stop value chain and has broader geographic and therapeutic reach.
• Charles River Laboratories: Global CRO with deep preclinical/GLP safety assessment and bioanalysis capabilities plus clinical services; directly comparable to Dt&CRO's Safety Evaluation Center and Bioanalysis Center but at much larger scale and global footprint.
• Labcorp Drug Development (formerly Covance): One of the world's largest CROs offering preclinical, clinical, bioanalytical, and central lab services under a single organization; the global benchmark for Dt&CRO's one-stop ambitions.
• Medpace: Mid-to-large global CRO specializing in biotech and small-to-mid pharma clinical trials; competitive overlap with Dt&CRO's emerging biotech customer base.
• ICON plc: Top-tier global CRO with extensive clinical, bioanalytical, and laboratory services; a relevant competitor for Korean biotechs seeking international trials, where Dt&CRO would compete for Phase 2/3 work.

Direct peers

• Joinn Laboratories: China-based preclinical and GLP safety assessment CRO with AAALAC-accredited facilities; a direct peer for Dt&CRO's Safety Evaluation Center, particularly in the Asia-Pacific biopharma market.
• Frontage Holdings: US-China based CRO with strong bioanalytical, PK/PD, and bioequivalence services — the closest functional analog to Dt&CRO's Bioanalysis Center and PK/PD Center offerings.
• Hangzhou Tigermed: Leading Asian clinical CRO offering Phase 1-4 services, data management, biostatistics, and regulatory support — competes head-to-head with Dt&CRO's Clinical Trial Business for Asian biotech clinical study wins.

Regional players

• Samsung Biologics / Samsung Bioepis: Korean biopharma players that anchor domestic CRO demand and may partner with or compete against Dt&CRO for biosimilar and biologics bioequivalence and clinical trial work in Korea.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCdtnrooMU5t2ZtMU7ZqS3Ig

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Subsidiaries6 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Dt&CRO