Serving the Medical Device industry since 1995.

We are a consulting firm specialized in the medical device and pharmaceutical industry. We will tailor our program to your very unique and specific needs. Our goal is to assist you in being successful on the short term by executing ad-hoc projects and on the long term by providing you with the tools to continue to grow.

Global
We have worldwide geographic experience from the United States to emerging markets: USA, Europe (France, Switzerland, Ireland, Scotland, The Netherlands), Singapore, Costa-Rica.

We can facilitate your projects across cultural and language barriers: fluent in English and French, and working Spanish.

FDA / European agencies
We have strong expertise of the FDA and European regulatory environments. We will help you “do it right the first time” and “do it fast”, while ensuring regulatory compliance.

Focus
Today’s business climate demands the highest level of professional skills and organizational efficiency. We will partner with you to provide the solutions you need to manage your business successfully. We focus on:

• Management Support
• Strategic Planning
• Project Management

• Operations / Manufacturing
• Manufacturing scale up
• Manufacturing transfers
• Lean manufacturing

• Quality / Regulatory
• Quality systems
• Process and product validations
• Internal / external Audits
• Working with FDA
  

• Product Development
  • Design control & development
• From R&D to manufacturing

• Professional Development
• Training