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Case Studies

Australian device company seeks help from Safis on 510k approval.

US pharma company engages Safis for Quality Systems.

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Other Resources

I am a company trying to launch a product into the US...

Links to International Ministries of Health

Message from the CEO

Clear guidance to global approval

...Because your product could improve the quality of life for millions abroad

The International Healthcare Market

Globalization for the life science industry means that a viable product should not remain in just the domestic market.  Rather, each product has the potential to improve lifes for millions around the world.  However, to reach its fullest peach product needs to pass various complexities and demands of regulatory standards. This critical process should not be left to chance but rather should be trusted with a business ally whose expertise you can depend on.

How Safis can help

We understand that you and your organization work fervently to ensure the quality of your life science product. We likewise work with this same passion to ensure that your products get to market as quickly as possible by providing clear solutions to overcome both domestic and international regulatory hurdles. To expedite this process, allow Safis to focus on the regulations aso that you can focus on the science and technologies.  Specifically, contact us to learn more about the following services we offer:

  • CE Marking
  • CFG
  • COFS 
  • MAA
  • IMPD
  • CTX
  • CTN
  • Site Audit
  • Certificate of Suitability 
 

 

 

 

 

 

 

Benefits of working with Safis

  • Peace of mind
  • Decreased risk of regualotry warnings
  • A relationship that can help you with future regulatory and quality compliance needs
  • Shorter time to market
  • Avoidance of unnecessary costs and delays
  • Access to broad international experience (See below.)

Where Safis has helped launch products

Safis has helped companies launch products in over 50 countries. Regardless of where you are, feel to contact us to learn how we can help serve your regulatory and quality compliance needs nearly anywhere in the world.

international map of safis operations

>>Learn more about Safis