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Integrated CDMO Platform

Integrated CMC PlatformAPI Process R&D and ManufacturingPreformulation StudyFormulation R&D and ManufacturingAnalytical Development and Quality Research (GMP)Regulatory Affair

Regulatory Affair

The regulatory affair team provides global documentation and filing services for innovative and generic drugs, including the regulatory gap analysis, preparation of the full set of documentation, communication and meeting arrangements with the regulatory authorities, translation of registration documents, regulatory support throughout the project, and submission of documents.

  •  Global Regulatory Strategies

  • Feasibility Assessment

  • Gap Analysis

  • Application Plan

  • Regulatory Guidance for R&D

Pre-IND meeting, etc

Take IND application as an example

  • CMC

    ◆ API:

    Process Research and Development, Manufacturing Process, Physical and Chemical Properties, Quality Research

    ◆ Formulation:

    formulation development, manufacturing process, Excipient Compatibility Study, Quality Research

    ◆ Quality Research – Impurities:

    Structure Identification and Analysis Methods of Impurity, Evaluation and Analysis Methods of Genotoxic Impurities, Control of Elemental Impurities

    ◆ Compatibility of Packaging Materials:

    Study of Extractables/Leachables of Packaging Materials and Pipes

     

  • Non-clinical

    Safety — PD — PK

    ◆ Pharmacodynamic Animal Model

    ◆ Non-clinical Animal Species/Model

    ◆ Bioanalytical Method

    ◆ Toxicology NOAEL

  • Clinical

    ◆ Adverse Event Reporting:

    Definition of Adverse Event, Classification, etc

    ◆ Objective and Endpoint of Clinical trials:

    Primary Objective and Secondary Objective

    ◆ Clinical Trial Background and Introduction:

    Information Research, Principles of Clinical Development, Expected Risks, etc

    ◆ Criteria for inclusion and exclusion of subjects

    ◆ Indicators of Clinical Laboratory Examination

    ◆ Plan for Data Management and Statistical Analysis

Paper or electronic submission to the regulatory authority system: IND, NDA, ANDA, consistency evaluation, etc