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

* 독성 시험 및 PK/PD 설계 등 성공적인 비임상 개발을 지원합니다.

• Strategy Consulting
  • Clinical study strategy for fastest approval, justification of indication
  • IND submission or approval
  • Functional support, including regulatory advice and quality audit
• Clinical Development and Operation
  • CRO/Country selection
  • Stepwise services for IND/NDA approval, indication extension
  • Insourced cPM

* 성공적인 국내외 임상 진입 전략 수립 및 파트너십을 관리합니다.

• 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, GxP compliance
• Process Life Cycle Management
• Cell Line Establishment and Characterization for Protein, cell/gene therapeutics:
  • Cloning, expression vector, host cell, MCB, WCB, cell bank stability

* 최적의 제조 공정 개발 및 글로벌 수준의 품질 관리 체계를 구축합니다.

• 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