Launch Projects / Readiness

Committed to success (or damned to success)

  • NCE / NBE launches are multi-disciplinary and long-lasting programs with a high degree of complexity
  • Successful launches contribute significantly to the long-term competitiveness of a pharmaceutical company, i.e. they have to be mastered effectively – time is money and zero-error-tolerance is a must
  • The role and program contribution of Technical Operations are essential and require detailed preparation and planning
  • Starting point for Technical Operations is a guiding mission clarifying scope and expected outcome of Technical Operation



Depending on the mission, the scope and complexity of implementation projects may vary – in general, launches address 10 major work streams in Production:

  • Launch supply chain design – e.g. definition of first / second manufacturer
  • Market demand forecast
  • Capacity demand planning inclusive gap analysis
  • Capacity and infrastructure build-up
  • Design to cost roadmap and CoGS optimization
  • Quality readiness with regard to manufacturability of DS and DP
  • Transfer program between R&D and first manufacturer
  • Launch supply strategy – i.e. definition of launch capacity, safety stocks, pipeline filling
  • Accompanying launch program planning and monitoring
  • Handover to routine phase


For each stream, we can provide project WBS – Work Breakdown Structure – templates ensuring completeness of activities and giving guidance regarding reachable best-in-class processing times.

The set-up of the corresponding program organization should follow some basic design principles: effective, focused, simple, manageable, and no overlaps. Very often these are not considered adequately, which leads to considerable delays during program execution.

Program organization should follow the motto “coming in parts but winning together” – the PMO (Program Management Office) is the integrating platform.

Typically, PMO is accountable for program planning, progress monitoring & reporting; the overall demand & capacity planning, the budget control (CapEx / OpEx), as well as accompanying communication & change management.


We at JSC have many years of experience in launch program management and have developed a tool box enabling the PMO to monitor and manage the program effectively and pro-actively (e.g. program with 10 workstreams, more than 30 projects, and ~ 2500 activities).


Launch Readiness Check – an instrument for the project management of global product launches

Best Practice (PDF)


Planning and management of global product launches in the pharmaceutical industry from the perspective of Production and Logistics

Best Practice (PDF)