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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
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
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:
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:
4. Provide the risk assessment results according to regulatory guidance
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
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
1. Propose the study items and their designs
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
3. Provide an Interpretation of the results and opinion on need for follow up studies
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
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
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
1. Formulation Development
4. Quality by Design (QbD)
5. Lyophilization and Spray Drying
6. Controlled Release Formulations
7. Stability Testing
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