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Global Regulatory Strategies
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Feasibility Assessment
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Gap Analysis
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Application Plan
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Regulatory Guidance for R&D
Pre-IND meeting, etc
Take IND application as an example
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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
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Non-clinical
Safety — PD — PK
◆ Pharmacodynamic Animal Model
◆ Non-clinical Animal Species/Model
◆ Bioanalytical Method
◆ Toxicology NOAEL
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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