A physiologically-based pharmacokinetic (PBPK) modeling and simulation (M&S) generate PK profiles of drugs

under various dosing regimens for virtual populations. PBPK is commonly used to support strategic

decision-making in clinilcal trial design, particularly for simuating drug-drug interactions and determining

dosing regimens for special populations.

PK-PD modeling combines pharmacokinetics (PK) and pharmacodynamics (PD) to describe and predict the

relationship between drug concentrations and their effects over time. This approach integrates the processes of

drug absorption, distribution, metabolism, and excretion (PK) with the drug's effects (PD). The outcomes of PK-PD

modeling include optimized dosing regimens, better understanding of drug efficacy and safety profiles, and

improved predictions of therapeutic and adverse effects in various target (patient) populations by modeling

current data and simulating what we wish to know. It is crucial for drug development, aiding in efficient trial

design, out-licensing purposes, and regulatory submissions, thereby enhancing the overall therapeutic strategy

based on the available data.

Noncompartmental analysis (NCA) is a method used in pharmacokinetics to evaluate drug exposure without

assuming a specific compartmental model. It is based on the statistical description of given pharmacokintic data

to provide a straightforward way to calculate various pharmacokinetic parameters. Key pharmacokinetic

parameters of NCA include AUC, CL, Vd, Cmax, Tmax and half-life of a drug. NCA can also be applied to

pharmacodynamic parameters to evaluate drug effects over time in a simplicitic manner. Key aspects of NCA for

PD parameters include AUEC, Emax, and Tmax.

A target candidate profile (TCP) means the desired characteristics of a preclinical drug candidate. Establishing

a TCP is essential for determination of a competitive preclinical candidates. We can help you set up your TCP

including desirable properties for physicochemical, pharmacolgy, pharmacokinetics and toxicology,

considering medical unmet needs and competitors.

In candidate selection stage, a number of candidates are evaluated and compared in several key experiments.

To find your competitive preclinical candidate, we can provide the study management services below:

  1. Propose the designs of experiments for screening

  2. Search the CROs and comparison of estimates

  3. Review the protocol and draft reports

  4. CRO management and communication

Time and cost are always limited, so a strategic approach is needed to find preclinical candidate with restricted

resource. Our expert team can give a strategic plan and process to select the final preclinical candidate quickly

and effectively. Our consulting consists of the following services:

  1. Propose the key study items for PK, pharmacology, toxicology

  2. Propose the screening tree

  3. Propose the milestone and criteria for decision making

In vitro pharmacology studies are biochemical and cell-based assays for investigating the target binding, target

engagement and mechanism of action. Our consulting consists of the following services:

  1. Propose disease relevant assay and its design

  2. Search the CROs and comparison of estimates

  3. Review the protocol and draft reports

  4. CRO management and communication

In vivo pharmacology studies are performed to confirm whether the potency and activity confirmed in vitro are

also implemented in vivo. Our consulting consists of the following services:

  1. Propose the human relevant animal model

  2. Propose the study design including dose levels and interval

  3. Propose appropriate competitors to compare the efficacy head-to-head

  4. Search the CROs and compare estimates

  5. Review the protocol and draft/final reports

  6. CRO management and communication

With extensive industry experience and regulatory expertise, our team is your trusted partner for bioanalytical

consulting services. We offer expert consulting services for bioanalysis to guide you through every development

stage. Regulatory compliance is a critical aspect of bioanalysis for IND and NDA submission, and our consultants

are well-versed in the latest regulatory guidelines and requirements. We can help you navigate the regulatory

landscape, prepare for regulatory submissions. Our consulting services cover a range of bioanalysis, including:

  1. Search the trust CRO and compare estimates

  2. Consulting and problem solving for method development and validation

  3. Review the protocol and draft/final reports

  4. CRO management and communication

In vitro ADME studies play a crucial role in drug development by providing essential insights into the

pharmacokinetic properties of drug. Our extensive network of trusted CROs ensures that you can find the

expertise and capabilities you need to execute your studies efficiently and effectively. We'll work with you to

identify CROs that align with your specific requirements and budget, saving you time and resources in the search

process. We understand that every drug development program is unique, which is why we offer customized

consulting solutions tailored to your specific needs. Whether you require assistance with study design, method

development, data interpretation, or regulatory compliance, our consultants collaborate closely with your team to

deliver personalized guidance and support. Our consulting consists of the following services:

  1. Propose the study list and its design

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Review the protocol and draft/final reports

  5. CRO management and communication

In vivo PK studies are essential for understanding the absorption, distribution, metabolism, and excretion of drug

candidates in living organisms. These studies provide critical data on the concentration-time profile of a

compound in the body, enabling the prediction of key pharmacokinetic parameters such as bioavailability,

clearance, and half-life. Our consulting services aim to guide you through the design, execution, and

interpretation of in vivo PK studies to support informed decision-making throughout the drug development. With

our extensive experience in drug development and pharmacokinetics, we offer tailored solutions to help you

navigate the complexities of PK studies and optimize your drug development process. Our consulting consists of

the following services:

  1. Propose the study list and its design

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Review the protocol and draft/final reports

  5. CRO management and communication

Drug-drug interaction studies are crucial for evaluating how multiple drugs interact with each other when

administered concurrently. These interactions can impact drug efficacy, safety, and pharmacokinetics, potentially

leading to adverse effects or therapeutic failure. Therefore, drug-drug interaction study should be conducted for

the metabolic enzymes and transporters in early drug development stage. Our consulting services aim to guide

you through the design, execution, and interpretation of DDI studies to ensure comprehensive assessment and

informed decision-making. Our consulting consists of the following services:

  1. Propose the study list and its design

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Provide the risk assessment results according to regulatory guidance

  5. Review the protocol and draft/final reports

  6. CRO management and communication

In vivo PK/PD studies are important to understand the relationship between drug exposure (pharmacokinetics)

and pharmacological response (pharmacodynamics). By integrating pharmacokinetic and pharmacodynamic

data, these studies provide valuable insights into the drug's efficacy, potency, and safety profile, guiding dose

selection, regimen optimization, and clinical trial design. Our consulting consists of the following services:

  1. Propose the study design for PK/PD modeling

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Review the protocol and draft/final reports

  5. CRO management and communication

In vitro toxicology studies play a critical role in evaluating the potential adverse effects of compounds on

biological systems, enabling the early identification of safety concerns and informed decision-making in drug

development. These studies aim to assess various toxicological endpoints, including cytotoxicity, genotoxicity,

carcinogenicity, and organ toxicity, using cell-based assays and tissue culture models. Our consulting consists of

the following services:

  1. Propose the study items and their designs

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Review the protocol and draft/final reports

  5. CRO management and communication

Safety pharmacology should be evaluated to identify undesirable pharmacodynamic properties of drugs on vital

physiological functions, such as the cardiovascular, respiratory, and central nervous systems. Therefore, safety

pharmacology studies should be performed separately or incorporated in repeat dose toxicity studies before IND

submission. Our consulting consists of the following services:

  1. Propose the study design for core battery studies

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results and opinion on need for follow up studies

  4. Review the protocol and draft/final reports

  5. CRO management and communication

General toxicology should be evaluated to identify the potential toxicity of drugs and include subchronic and

chronic toxicity studies in rodents and nonrodents models. Therefore, general toxicity studies should be

performed before IND submission. Our consulting consists of the following services:

  1. Propose the species for toxicology studies considering metabolite profile and type of drugs

  2. Propose the study design including dose levels, dosing intervals, recovery period and toxicokinetics

  3. Search the CROs and compare estimates

  4. Provide an Interpretation of the results

  5. Review the protocol and draft/final reports

  6. CRO management and communication

Other toxicology studies are conducted to evaluate specific adverse effects that drugs might have under

particular conditions. These studies aim to identify and characterize potential toxicities, such as phototoxicity and

immunotoxicity, that may not be detected in general toxicology assessments. Generally, other toxicity studies

include studies to evaluate phototoxicity, immunotoxicity, dermal toxicity and ocular toxicity, etc. Our consulting

consists of the following services:

  1. Propose the study items and study designs

  2. Search the CROs and compare estimates

  3. Provide an Interpretation of the results

  4. Review the protocol and draft/final reports

  5. CRO management and communication

Preformulation studies are a critical component of the drug development process, laying the groundwork for

successful formulation and production. Through the preformulation studies, you can understand the

physicochemical characteristics of your drug substance and identify the potential risk related to stability, solubility

and compatibility at early development stage. We can provide specialized consulting services in preformulation

studies within the Chemistry, Manufacturing and Controls (CMC) area and will offer a wide range of

preformulation consulting services tailored to meet the specific needs of your drug development project.

Formulation studies are essential to the successful development of pharmaceutical products. They play a critical

role in transforming a drug substance into a final product that is safe, effective, and manufacturable. We provide

a comprehensive range of formulation consulting services designed to address every aspect of drug product

development. Our services include, but are not limited to:

  1. Formulation Design and Development

  2. Excipient Selection and Compatibility

  3. Process Development and Optimization

  4. Lyophilization and Spray Drying

  5. Controlled Release Formulations

  6. Stability Studies

  7. Scale-Up and Technology Transfer

  8. Analytical Method Development and Validation

  9. Regulatory Support

The drug substance, or active pharmaceutical ingredient (API), is the core component of any pharmaceutical

product. Proper development and manufacturing of the drug substance are critical for ensuring the safety,

efficacy, and quality of the final drug product. We offer a wide array of consulting services designed to optimize

every aspect of drug substance development. Our services include, but are not limited to:

  1. Process Optimization

  2. Scale-Up Support

  3. Crystallization Development

  4. Analytical Method Development and Validation

  5. Impurity Profiling and Contro

  6. Stability Testing

  7. Regulatory Documentation and Support

  8. Quality by Design (QbD)

Drug product development is a critical phase in the pharmaceutical lifecycle, transforming the active

pharmaceutical ingredient (API) into a final dosage form that can be safely and effectively administered to

patients. We offer a wide range of consulting services designed to address every aspect of drug product

development. Our services include, but are not limited to:

  1. Formulation Development

  2. Excipient Selection and Compatibility

  3. Process Development and Optimization

  4. Quality by Design (QbD)

  5. Lyophilization and Spray Drying

  6. Controlled Release Formulations

  7. Stability Testing

  8. Analytical Method Development and Validation

  9. Technology Transfer

  10. Regulatory Support

We offer a gap analysis service to evaluate the data available from our clients before preparing IND submission

package or moving onto the next step of development. This service identifies any missing information or

deficiencies in the existing data, ensuring that all requirements are met before IND submission. Our experts from

nonclinical, clincal, CMC and regulatory team will be involved to review the existing data and provide

comprehensive assessment result to clients.

Establishing a strategy for nonclinical development is important to complete the development successfully for

phase 1 clinical trials. The development strategy should be established considering Target Product Profiles (TPP)

and clinical development strategy. Our specialized consulting service can support your drug development

program by providing development strategy and plan within limited resources and target time for phase 1 clinical

trials.

IND-enabling nonclinical study encompasses a series of scientific evaluations and tests conducted before

initiation of human clinical trials for a new drug candidate. These studies should be designed to generate the

essential data required to support an Investigational New Drug (IND) application to regulatory authorities. Our

specialized consulting service can support your drug development program by providing expert guidance and

comprehensive solution that ensure IND application meets regulatory standards and advancees through the

approval process.

Our company offers comprehensive services to facilitate the submission and approval of IND applications. In

addition to managing the entire submission process, we provide expert regulatory consulting to support your

needs. Our consulting services include guidance on regulatory strategies, preparation, and adequacy evaluation of

documentation, and identification of any missing information. We ensure your submissions meet all regulatory

requirements and help you navigate the complexities of the approval process.

Preparing an IND (Investigational New Drug) dossier is a crucial step in regulatory affairs for initiating clinical

trials. It involves collecting and organizing comprehensive data on the drug's preclinical studies, manufacturing

details, and proposed clinical trial plans. The dossier must demonstrate the drug’s safety and potential efficacy to

regulatory authorities. Key components include the Investigator's Brochure, Chemistry, Manufacturing, and

Controls (CMC) information, nonclinical study results, and detailed clinical protocols. Accurate and thorough

preparation of the IND dossier is essential for obtaining regulatory approval to proceed with human trials. Before

development of the IND dossier, our experts of nonclinical, clinical and CMC perform evaluation of adequacy of

existing data for IND submission to health authorities(FDA, EMA, MFDA, etc.). Also, missing data is identified

during this evaluation. IB, IMPD, CTD and PRT are developed by our experts and reviewed by regulatory

strategy/affairs team.

We specialize in providing comprehensive services to facilitate the submission and approval process of IND

applications. Our expert team ensures that all documentation is meticulously prepared, evaluated for adequacy,

and submitted in compliance with regulatory requirements. We also identify and address any missing information

to streamline the approval process.

Comprehensive services for optimized clinical development strategy including, but not limited to:

  1. Development of clinical stragetic roadmap including early stage clinical development plan(CDP) and target

    product profile(TPP) regarding market landscape assessment, standard of care, clinical guidelines and

    regulatory considerations.

  2. Prioritizing target population(indication), treatment positioning, route of administration etc.

  3. Strategies on indication expansion

Comprehensive services for regulatory strategy development including, but not limited to:

  1. Regulatory supports on preIND/IND submissions

  2. Regulatory supports on NDA/BLA submissions

  3. Rare disease/orphan designation

  4. Feasibility assessment for expedited programs

  5. Regulatory vendor selection etc.

Comprehensive services for planning and conducting early phase clinical study including, but not limited to:

  1. Development of clinical pharmacology studies including first-in-human(FIH), SAD/MAD, food effect, DDI,

    cardiac safety studies and studies in special populations and others.

  2. Development of seamless and efficient early phase designs, from dose-finding to efficacy exploration

  3. Strategies for expedited approval programs such as accelerated approval

  4. Clinical study synopsis and protocol/ICF writing

  5. Support for US FDA preIND meeting and IND submission

  6. Clinical/regulatory Ventor selection and management

  7. Regulatory supports on preIND/IND/NDA submissions, rare disease/orphan designation and feasibility

    assessment for expedited programs etc

Comprehensive services for planning and conducting late phase clinical study including, but not limited to:

  1. Development of seamless and efficient late phase designs for confirmatory trials

  2. Strategies for expedited approval programs such as accelerated approval

  3. Clinical study synopsis and protocol/ICF writing

  4. Support for US FDA preIND meeting and IND submission

  5. Clinical/regulatory Ventor selection and management

  6. Regulatory supports on preIND/IND submissions, rare disease/orphan designation and feasibility assessment

    for expedited programs etc

Providing Expert Study Management Services for Clinical Research Excellence including, but not limited to:

  1. Vendor Selection: Optimize study quality and efficiency through meticulous vendor selection, ensuring

    reliability and transparency.

  2. Start-up Coordination: Systematically manage pre-study activities, including IRB approvals, team training, and

    material preparation for a successful study initiation.

  3. Site Initiation and Oversight: Oversee site initiation and routine monitoring, collaborating closely with sponsors

    and investigators to optimize operations and address issues promptly.

  4. Study Conduct and Monitoring: Ensure data integrity with customized monitoring strategies and skilled staff

    for effective implementation.

Supports on various unsolved challenging tasks for clinical drug development and approval of the product

including, but not limited to:

  1. Communcation with regulatory bodies, solutions for MFD/FDA/EMA review comments, etc

  2. Determination of sample size

  3. Integration and analysis of clinical study data

  4. Patient safety & pharmacovigilance

  5. Provides customized solutions for other specific issues upon request