Precision in Nonclinical Research!

Driving innovation in Nonclinical Research to accelerate your success.

View More Information

Your Partner in Nonclinical Success!

Partnering with you to advance drug development through science, speed, and accuracy.

More Information

Advancing Research, Ensuring Quality!

Helping you bridge the gap from discovery to clinical success with precision and expertise.

More Information

About Us

Your Trusted Partner in Nonclinical Research!

QuBEST Bio provides specialized services ranging from the discovery of drug candidates for new drug development to lead optimization and nonclinical studies supporting IND applications. We are committed to offering end-to-end support through customized solutions tailored to our clients, including integrated consulting for drug development, data analysis, and project management.
In addition, we possess scientific and regulatory expertise in both GLP and non-GLP studies, as well as in new drug research and development (R&D). Building on numerous successful cases, we continue to strengthen our position as a “Preferred Preclinical Partner!”.

Tailored Non-clinical Strategy for Successful Clinical Entry!

We provide nonclinical strategies optimized for the specific characteristics, development goals, and stages of each development pipeline. From the early stages, we support the establishment of tailored nonclinical strategies that minimize potential risks and unnecessary resource expenditure, while efficiently generating the key data required for successful entry into clinical development.

About Us

Proactive, motivated, and focused

  • Provision of appropriate nonclinical study services and study design consulting at each stage of R&D, based on researcher-centered thinking and decision-making
  • Management of IND toxicology projects, including preclinical study design and monitoring suitable for regulatory submissions
  • Delivery of strong teamwork built on a win-win partnership approach
  • Annual outsourced nonclinical testing services during research and candidate optimization stages (Nonclinical Evaluation Center: Efficacy, PK/PD, Single-dose and DRF toxicity, etc.)

Learn More     

More Information about QuBEST Bio

Person

Company History

For the past 18 years


Person

Our Expertise

To help you better

Pharmacology / DMPK / Toxicology Data Analysis
We perform in-depth analysis of generated nonclinical data (pharmacology, DMPK, and toxicology) to comprehensively evaluate pharmacological mechanisms, pharmacokinetic properties, druggability, and safety issues. Based on this, we provide customized solutions tailored to each stage of development.

Gap Analysis
We review data suitability against regulatory requirements and establish supplementation strategies. By reviewing and analyzing essential nonclinical data required for clinical entry and IND approval, we assess whether the currently available data meet the latest regulatory requirements of authorities such as the FDA, MFDS, and EMA. We identify items that require supplementation and support the development of efficient remediation strategies to proactively eliminate factors that could delay development.

Modeling & Simulation
We support human exposure prediction based on PS&DMPK data. Through modeling and simulation using available nonclinical data (PD and DMPK), we rationally estimate expected in vivo exposure in early clinical studies, thereby supporting appropriate clinical dose setting and ensuring the scientific validity of clinical trial design.



Our Strengths and Values!

Predictive Insights

Based on long-term development project execution know-how, we identify potential safety and efficacy-related risks that may arise during the nonclinical process at an early stage. We support decision-making on alternative strategies and development directions to overcome these risks, thereby increasing the likelihood of project success.

Regulatory Readiness

We support the preparation of data that complies with guidelines and the latest requirements of major global regulatory authorities, including the FDA, MFDS, and EMA. By ensuring that the required regulatory standards are met, we help secure data that minimizes potential risks during the approval process.

Optimized Planning

Through the establishment of accurate nonclinical strategies, we reduce unnecessary studies and redundant testing, enabling more efficient use of limited resources. This contributes to cost reduction and shorter development timelines.

Accelerated Success

By establishing efficient nonclinical strategies and securing robust nonclinical data, we help accelerate the path to clinical entry and support the development of competitiveness that enables successful business outcomes in technology transfer and partnering processes.

Knowledge

Based on deep understanding and know-how in the pharmaceutical industry and drug development, we provide optimal solutions to our clients.

Experience

We successfully handle 5–7 U.S. FDA Investigational New Drug (IND) applications annually, demonstrating experience driven by tangible outcomes.

Project Management

Professional project manager (PM) lead project success through systematic management and schedule coordination.

Network

We collaborate with more than 20 CRO organizations, demonstrating global-scale project execution capabilities.

Collaboration

Through MOUs with Q-fitter, 3D organoid, and AI companies, we are able to conduct collaborative research based on convergence technologies.

Passion

Driven by an unwavering passion for client success, we proudly maintain a high satisfaction rate, with more than 90% of clients returning for repeat engagement.

QuBEST BIO Methodology

This is where innovation takes a different path!

QuBEST BIO is more than just a Contract Research Organization (CRO); it is a nonclinical CRO that grows together with its clients and creates value. Guided by three core philosophies—“Smart Budgeting & Shared Success,” “Agile Communication & Collaboration,” and “Expertise & Execution”—we support every stage of your drug development journey.

From Strategic Planning To Execution!

From the early stage of development strategy planning through nonclinical study design, CRO selection and management, and ultimately IND approval, we provide integrated and specialized consulting and support across the entire process, positioning ourselves as your best partner for successful clinical entry.

"Smart Budgeting & Shared Success"

Through reasonable costs and sustainable value, we offer more efficient and competitive pricing while maintaining research quality. In addition, as a collaboration-oriented CRO that creates sustainable value together with our clients, we take pride in our high rate of repeat engagements and long-term partnerships.

"Agile Communication & Collaboration"

Through smooth communication and strong partnerships with our clients, we work closely with your research team as an agile CRO that responds quickly to changes. As a true “partner working together,” we go beyond simple outsourcing and build trust as a strategic collaborator toward shared goals.

"Expertise & Execution"

Based on expertise and hands-on experience, QuBEST BIO is a hands-on, execution-driven professional CRO that directly conducts the entire process of experimentation and R&D. Drawing on extensive drug development experience and accumulated know-how, we go beyond theory to deliver practical, tangible results.

Our Services

Partnering with you, every step of the way!

QuBEST BIO provides one-stop nonclinical study services required throughout the entire drug development process. Based on world-class scientific expertise and analytical platforms, we enable faster and safer clinical entry through customized strategies and precise data tailored to each client.

Pharmacology

We leverage a deep understanding of various disease models and validated experimental platforms to provide accurate and reproducible data on whether a client’s candidate compounds are truly suitable for clinical development.

  • Good track record in anti-cancer xenograft, CIA, IBD, etc.
  • Bioanalytical support in plasma and target tissues
  • Flexible design and various dosing route/frequency (PK/PD relationship)
  • In vitro molecular endpoints
  • Safety/translational read-outs
  • Data interpretation

Lead Optimization Toxicology

Based on a wide range of in vitro and in vivo toxicology evaluation platforms, QuBEST BIO scientifically analyzes the balance between pharmacological activity and toxicity. Through this, we support the selection of safer and more effective lead compounds.

  • Good track record in non-GLP lead optimization toxicity in rodents/dogs
  • Flexible design and various dosing route/frequency (Rat/mouse/rabbit/ferret/dog, Single/MTD, 7-, 14-, 28-day DRF with TK)
  • Bioanalytical support in plasma (LC-MS/MS bioanalysis)
  • Highly experienced in vivo team with good skills
  • PM team scientific support toin-house staffs

Pharmacokinetics and In vitro ADME

QuBEST BIO supports efficient compound optimization prior to clinical entry through pharmacokinetics (PK) and in vitro ADME-based drug property evaluation of candidate compounds.

  • Broad range of in vitro ADME/transporter assays
  • In-house flexible PK (single and multiple dosing in various species)
  • PK/TK parameters and data interpretation
  • PK/PD modeling (NONMEM®)
  • Human PK prediction


DMPK (Drug Metabolism and Pharmacokinetics)

DMPK is a key research field that scientifically analyzes how drug candidates are absorbed, distributed, metabolized, and excreted in the body, ensuring a balance between efficacy and safety. Based on global-level analytical capabilities, QuBEST BIO provides strategic DMPK services to help select candidates with high clinical development potential.

Absorption

  • In vivo PK (IV/PO/IP/....)
  • PAMPA
  • Caco-2 permeability (subcontracted)
  • Biostatistics

Distriburion

  • Tissue distribution (In vivo)
  • Plasma protein binding
  • Tissue binding
  • Brain distribution (In vitro)

Metabolism

  • Microsomal metabolic stability
  • Plasma stability
  • CYP reaction phenotyping
  • CYP inhibition (IC50)
  • Time dependent inhibition (IC50 shift)

Excretion

  • Urinary & fecal excretion
  • Biliary excretion

Bioanalysis

Bioanalysis is a core technology that quantitatively analyzes how drugs and their metabolites exist and change in biological samples such as blood, plasma, and tissues. QuBEST BIO provides highly reliable bioanalytical services using high-sensitivity LC-MS/MS platforms and validated analytical protocols.

LC-MS/MS, HPLC

  • AB sciex, Tripe Quad 6500+
  • AB sciex, 4500 Q trap
  • Agilent, 1290 Infinity II

Method development and sample analysis

  • Selectivity, matrix effect, carry-over, LLOQ
  • Calibration curve, accuracy, precision
  • Recovery, dilution integrity, stability

Fit-for purpose non-GLP research

  • Grade assay to prepare method development and validation

In vitro Molecular Assay and Screen Genotox

In the early stages of drug development, it is critical to simultaneously evaluate “How a compound works” and “How safe it is” QuBEST BIO provides integrated analytical services that enable early identification of scientific potential and potential risks of candidate compounds through in vitro molecular mechanism assays and genotoxicity screening.

Biomarker assay

  • Cytokine assay(GCSF, IL-4, IL-6, TNF-α)
  • Insulin, glucose, Free fatty acid
  • Histopathologic evaluation

ELISA assay

  • Antibody/Protein analysis
  • Growth factor / Hormone analysis
  • Virus, allergen Diagnosis

Real Time PCR

  • Gene expression assays
  • Biodistribution assessment of Gene & stem cell
  • Genotyping

Screen genotoxicity

  • Standard Ames, Mini AMES
  • TA100, TA98, TA1535, TA1537, E-coil

Fit-for purpose non-GLP research

  • Grade assay to prepare method development and validation

Integrated Services for IND/NDA Clearance

One of the most important milestones in early drug development is Investigational New Drug (IND) clearance. We provide a full lifecycle integrated solution to help accelerate and streamline this process. For new chemical entities (NCEs), IND submission can typically be achieved within 9 months to 1.5 years, and for biologics within approximately 2 years. This timeline reduction is achieved not only through experimental execution, but through strategic planning and stepwise integrated project management.

Global

Your ideal research partner for success!

“ Based on accurate and highly reliable nonclinical research, we systematically conduct safety and efficacy evaluations from the early stages of drug development. We are equipped with state-of-the-art research facilities and experimental systems aligned with global standards, and our experienced research team is fully committed to delivering the highest-quality results. Moving forward, QuBEST Bio Co., Ltd. will continue to act as a trusted partner that supports our clients’ drug development success and grows together with them, grounded in scientific rigor and ethical responsibility. ”

Soohyeon Kim President & CEO

“ At QuBEST Bio, we are a trusted CRO providing top-tier nonclinical research services, and we continuously strive to support the successful development of our clients’ new drugs. In the rapidly evolving bio and pharmaceutical industry, we are committed to maintaining competitiveness while prioritizing accuracy and reliability in research. With a strong focus on client-centered services and uncompromising quality, we aim to contribute to the advancement of the global bio and pharmaceutical industries. ”

SeungHyun Sung Vice President

“ QuBEST Bio Co., Ltd. provides reliable research data based on world-class nonclinical research technologies and expertise. Since accurate and highly reproducible results are essential for successful drug development, we continuously strengthen our research capabilities to achieve this goal. Our experienced research team produces trustworthy data that helps our clients accelerate and streamline their R&D processes more efficiently. ”

JongHwa Go Executive Vice President

Facilities and Equipment

Empowering Discovery Through World-Class Facilities!

  • All
  • High Quality Vivarium Space and Laboratory
  • Bioanalytical, Analytical and in vitro ADME Laboratory
  • In vitro molecular Laboratory

High Quality Vivarium Space and Laboratory Area

Bioanalytical, Analytical and in vitro ADME Laboratory

In vitro molecular Laboratory

Contact Us...

Get in Touch with Us!

QuBEST BIO is always ready to accompany you on your research journey.
If you have any questions about nonclinical studies, strategic consulting, or partnerships, please feel free to contact us at any time.

To request more information about QuBEST or to inquire a service proposal, please email us at info@qubest.co.kr or call us at +82-31-706-2995.

* These fields are required.