Our Services

• Project analysis and management

• Study items, project schedule and budget analysis

• Study design proposal complying ICH guidelines

• Protocol and report review and preparation

• ​Study monitoring and audit plan/execution

• PK simulation and dose level justification

• Clinical stage-dependent nonclinical program design

• Strategy Consulting​

  • ​Clinical study strategy for fastest approval, justification of indication 

  • IND submission or approval

  • Functional support, including regulatory advice and quality audit

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• Clinical Development and Operation

  • CRO/Country selection

  • Stepwise services for IND/NDA approval, indication extension

  • Insourced cPM

• Supplier Review

• Product Characterization and QbD: TPP, QTPP, CQA determination

• Formulation Development and Stability:

  • Pre- and final formulation, container closure system, stability with storage condition

• USP/DSP Development and Scale Up:

  • Risk assessment, process validation, analytical method validation, comparability, release and stability data, document review and writing

• CRDMO Management: CRO, CMO evaluation, monitoring, GxPcompliance

• Process Life Cycle Management

• Cell Line Establishment and Characterization for Protein, cell/gene therapeutics: Cloning, expression vector, host cell, MCB, WCB, cell bank stability

• Due Diligence Support

• Gap Analysis and Closing Plan

• Documents/Raw Data Review and Evaluation

• Pipeline Evaluation

• Regulatory Affairs

• Submission and Approval of IND/NDA

• Respond to Regulatory Agencies

• Search CRO/CMO: Evaluation, Selection and Price Negotiation

• Contract and Budget Review: Risk and Hidden Cost Analysis