Context & challenge

  • Global Life-cycle management to provide efficiency and cost saving for the client, including standardized submission processes and local regulatory intelligence.
  • Initial Filing: Support to the strategic roll out plan and speed up the Go-To-Market. We put in place a systematic approach to predict project risks related to targeted submission dates and approved budget.
  • Regulatory Operations: ensure US/EU/Asian operations and expertise with the objective to support business continuity and absorb high volume for strategic projects related to new submission or new tool. RIM completion, Publishing, Labeling.

PLG team’s impact

PLG supported transition of life-cycle management activities worldwide on a country-by-country basis:

Key Deliverables

  1. Project Management: Proactive and effective project management to ensure objectives are achieved and delivered within agreed timeline and budget, to meet client’s expectations.
  2. Budget control: Realistic cost estimation and close monitoring and tracking of project activities to ensure project is completed within approved budget.
    solutions to ensure continuity of activity or additional support.
  3. Strategic Planning: Effective project planning, allocation of resources and coordination of activities  while minimizing risks, disruptions and uncertainties to optimize project success.
  4. Global Reg Intelligence: Gather, collect and analyze regulatory intelligence for the development of robust regulatory strategies.


  • 80+ countries and 23 brands
    Number of country and brand impacted by the global deployment
  • 80+ PLG headcount
    Staff deployed to support the program in both outsourcing and insourcing basis
  • PLG Partner Network
    Supporting Life-cycle management and initial filing activities globally.

Register to our news and events

Go to our Events to register
Go to our News to get insights

Global Life-Cycle Management, Initial Filings & Reg Ops