About CDRO

Contract Development
& Research Services

CDRO is a research and development outsourcing service that enables companies to develop new therapeutics and launch them in the market. It offers comprehensive research and development services, including CMC test method design and process development, test execution, data management, regulatory compliance, and statistical analysis.

With over ten years of experience in biosimilar development and EMA/FDA approvals, INEXOPLAT is the best team for biologics development.

INEXOPLAT provides services to support clients in obtaining approvals for their products.

INEXOPLAT supports pharmaceutical and biotech in product development, non-clinical material production, and non-clinical research, requiring CMC analysis.

Services Scope

  • Method Development 시험법 개발

    Develop an appropriate test method that can evaluate the quality of samples by selecting appropriate test methods according to the nature of the drug and analyzing the effects of these variables on the results by setting parameters that can affect the test method

    Development and evaluation of testing methods based on ICH Q2 considering the purpose/state of development such as accuracy (repeatability) Precision (repeatability) / specificity / linearity

  • Test analysis for early-stage sample for evaluation 평가를 위한 초기 단계 검체에 대한 검사 분석

    If there is a previously developed test method, a test for a specific sample is conducted according to the SOP. It can be used for simple analysis such as screening of early-stage substances without developing a separate test method

    * If there is no existing analysis method, "Development of testing method" should be combined.

  • Method Qualification 시험법 적격성 평가

    Steps to set up acceptance criteria for validation of testing methods

    Selection of acceptance criteria based on ICH Q2 considering factors such as accuracy (repeatability) Precision (repeatability) / specificity / linearity / robustness / reproducibility (intra-assay)

  • Tech Transfer 기술 이전

    Technology transfer of the developed test method to the client or consignee can be done (Analysis by INEXOPLAT’s expert is carried out in parallel if necessary)

    The operator of the company receiving the technology transfer (experiment with INEXOPLAT's experts if necessary) conducts an analysis to assess whether the acceptance criteria from the test method qualification stage are met

  • Consultation (Design of analytical scheme) 전략 자문 (분석 계획 수립)

    Establish an advisory and analysis plan to derive test items suitable for the customer's product and develop analysis methods

Service Workflow

  • Request for Proposal 실험 의뢰

  • Preliminary or Kick-off 사전 미팅

  • Assay or Development 분석 및 개발

  • Reporting & Documentation 보고서 작성 및 완료