In a world of challenging and dynamic regulations, effective management of product development, regulatory issues, or manufacturing scale up or transfers is essential to the maintenance of your business and to new product introduction. This necessitates a robust system to develop and manage projects with cross-functional teams.

On a small or large scale, direct integration of activities is essential to the successful regulatory approval and commercial launch of new products.

We will guide you in applying project management processes (including definition, planning, risk management, process control and change management) to ensure that activities are carried out according to timelines and within budget.

  • Define project scope and strategy and track project accordingly.
  • Lead project team to formulate a project pan and define critical path activities that ensure the most efficient route to approval while maximizing the product’s commercial potential.
  • Define, establish and rigorously monitor go/no-go criteria for all key project decision time points.
  • Identify project issues and risks and lead development of contingency and risk mitigation plans.
  • Lead cross function teams, facilitate discussions and provide conflict resolution.
  • Manage day-to-day operational aspects of projects and liaise with external businesses.
  • Communicate project updates and challenges with Executive Management via written and verbal presentations.
  • Pro-actively manage issues that may arise and ensure cost effectiveness of all aspects of project.

Our goal is not only to manage your specific project, but also to provide you with user friendly tools to facilitate implementation and execution of future projects.


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Gloster Biomedical International • 577 N. Hope Ave, Suite 101 • Santa Barbara, CA 93110 • USA • Tel: +1-805-679-1258

Copyright © 2008-2009 Catherine Gloster - Gloster Biomedical International - All rights reserved.