Our project managers are knowledgeable in the phases of product development from pre-clinical through commercialization.

They understand the critical interface with Pre-Clinical, Clinical, Regulatory, Marketing, and Chemistry, Manufacturing & Controls (CMC) areas to achieve targets for developing new products.

Skills

  • Project charter development
  • Scope and change management
  • Timeline development and critical path analysis
  • Stage-gate process management
  • Stakeholder management
  • Cross-functional team leadership and motivation
  • Global and/or virtual team management
  • Effective meeting facilitation, documentation, and follow-up
  • Team member accountability
  • Risk assessments, budgets, resource plans, and agendas
  • Knowledge of industry regulations

Projects

  • New Drug Development
  • New Device Development
  • New Indications
  • New Delivery Systems
  • Drug/Device Combinations
  • New Dosage Forms
  • Rx-to-OTC Switches
  • Regulatory Agency Filings
  • Clinical Trials (Phases I, II, and III)
  • Regulatory Agency Review Meetings
  • Drug Labeling Development
  • Alliance Management

FlexPro Experts

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