International Company Assistance
Global drug development can be a costly and lengthy process. While international drug discovery efforts have similarities throughout the world, navigating through the FDA approval process requires specific expertise that even global pharma companies may lack.
IRISYS has served as the U.S. FDA consultants for numerous foreign companies. We can help global pharma companies create strategies to take their new drug products through the entire FDA regulatory process. We offer customized drug development services that support the special needs of our international clients.
IRISYS is privileged to have worked with global pharma companies of various sizes in Australia, China, Japan, Korea and Russia. We can assist top global pharma companies as well as small enterprises with no global drug development experience.
Bringing a client’s product into the U.S.
IRISYS helps international companies by:
- Providing strategy and guidance throughout the U.S. FDA approval process
- Meeting at the client’s location or hosting representatives at IRISYS
- Providing translations of global drug development documents
- Educating the client’s personnel about FDA regulatory requirements