As a start up, or mid-size company, it may be daunting sometimes to focus on the short term of developing or improving a product and planning ahead for clinical trials, manufacturing, regulatory submissions, marketing.

Develop a strategic plan
In close collaboration with your management team, we will layout a realistic plan including all activities that can be done concurrently so that you can manage your human and financial resources optimally. We will identify key milestones and what it takes to achieve them.

We are here to help you strategize your operations to avoid the traditional pitfalls such as:

  1. Being behind schedule,
  2. Being over budget,
  3. Missing key expertise at decision milestones,
  4. Having a quality system that is ineffective,
  5. Having to repeat long testing,
  6. Delaying regulatory submissions,
  7. Delaying animal or FIM clinical trials.

Our motto is to “do it right the first time”.

→ It takes careful planning ahead, across functions,
to truly identify the steps lying ahead.

We will help you plan product development, preclinical testing and clinical studies. We will also provide support for 510K, IDE, PMA and CE mark submissions.

Path from concept to commercialization
We will take a global business perspective and develop, with you, a path from the concept/prototype to commercialization, via clinical trials and regulatory approval. We will present you with options and solutions.
We can also continue to support your organization throughout the implementation of your strategy to stay on course. It is an opportunity to review progress with a fresh look and think out of the box.

Due Diligence
When selecting potential acquisition, you may choose to use a combination of internal and external expertise.

You may consider acquiring another business to:

    1. Acquire patents, cutting edge technology
    2. Create a world class capability
    3. Integrate your business vertically
    4. Broaden your market share
    5. Acquire potential breakthrough product sales

To analyze the possible transaction rationale and to determine if the acquisition will create value for you, we will help you performing due diligence of possible business candidates.

Our expertise will be focused on the technology and operations analysis. We will use a comprehensive approach.

For example, we will provide an analysis of the evaluated company on the following:

  • Review of patents and know-how as input to your legal counsel
  • Product development productivity
  • Manufacturing and operations
  • Management
  • Quality and regulatory status
  • Competitive environment
  • Risk analysis


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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.