Consulting Service

Consulting Service

LSK Global PS has expertise and experience required for the development lifecycle starting from the establishment of initial development strategy to the strategies for CMC, preclinical study, clinical study, IND/NDA, etc. in the development of medical technology including new drugs

Strategic Consulting

LSK Global PS carries out the customized development strategy satisfying customers’ demands based on the specialized knowledge of extensive new drug developments and the deep understanding of domestic and foreign market environments and regulatory guides.
In addition to the establishment of strategy for new drug development, LSK Global PS provides customers with multidisciplinary services to help them realize the opportunities for new drug development by allowing them to lead a successful product development through organic collaboration with medical advisors, new drug development experts in the medical and industrial worlds, and statisticians.

Global Product Development

LSK Global PS can provide prompt and efficient supports to the domestic customers planning overseas expansion and the foreign customers planning to introduce their products into Korea, with its close networks constructed with the worldwide CRO partners in North America, EU, Japan, Taiwan, China, Southeast Asia, Australia, and so on. LSK Global PS is also providing the services of pipeline discovery, license-in & out, and joint clinical development along with clinical trials matching services.

Consulting Service

Consulting
Services

  • Strategy of integrated development planning
  • Non-clinical development plan
  • Clinical development plan
  • CMC development
  • Strategy of regulatory preparation

Service Scope

Strategy of integrated development planning

  • Target product profile
  • Integrated strategy including development milestones
  • Technology transfer: planning and execution
  • Competitive product information
  • Unmet medical needs and market access
  • Time and budget outline for development plan
  • Global advisory board meeting organization
  • Preparation for disclosure at international conference to global partners, etc.

CMC development

  • Milestone of required packages for CMC dossier
  • Manufacturing process: qualification, validation, critical quality and process attributes
  • CMO selection and review of CMO reports
  • GMP audits
  • Comparability strategy
  • Stability test plan & packages

Non-clinical development planning & clinical development

  • Review and interpretation of non-clinical report
  • CRO(GLP) selection and assessment of proposals
  • Development and proposal of clinical study
  • Rationale of product use, target population for development
  • Sample size determination
  • Selection of primary and secondary endpoints
  • Review and interpretation of clinical data
  • Requirements for first-in-human studies vs. pivotal studies

Strategy of regulatory preparation

  • Trend-setting, interpretation and assessment of regulatory requirements
  • Gap analysis (Dossier review)
  • Strategy consulting of bridging Study
  • Regulatory benefit-risk determination throughout all development and approval phases
  • Scenario planning for IND and NDA
  • Strategy and planning for MFDS meetings
  • Global expansion strategies for successful FDA/PMDA/EMA approval

Experience

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[Updated on 2019.12.31]