Regulatory Affairs Consulting - IRIS GLOBAL LLC

Pharmaceutical ManufacturingUnited States2-10 Employees

IRIS Global is a consulting firm that specializes in and understands the regulatory environment across Latin America and the Caribbean.  Just as important, we also understand the culture and business practices that are required to be successful, from the smallest island to the powerhouse of Brazil.   We work and support companies who:

• Would like to enter or expand into a Latin American or ROW
• Struggle with incomplete or poor regulatory filings causing products to lose marketing authorizations (market share)
• Feel that the regulations are constantly changing, causing rework and delays
• Cannot find the skilled and experienced resources to keep up with the regulatory demands.
• Have a regulatory team focused on the U.S., Europe or Asia but do not have a team that fully understands Latin America

We can answer your regulatory questions and/or  act as your regulatory affairs group for a specific country or for the entire region.  We can prepare your product dossiers, file in-country, respond to health authority questions and monitor a submission’s progress through approval.  

With our team in the U.S. and our specialists in  major countries, we offer a full set of capabilities that are normally only available to the largest companies.

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