Global Life-Cycle Management, Initial Filings & Reg Ops

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

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.