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.


  • 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


  • 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

Subscribe Today!
Gain instant access every month to the latest resources and insights from top experts in the industry. Sign up below to get started.
Sign up below to get started.