PHARMACEUTICAL, NUTRITIONALS, COSMETICS AND MEDICAL DEVICE

IRIS GLOBAL works with clients on a variety of commercial management models. With an innovative " Globlocal™" strategy, IRIS GLOBAL acts as its main regulatory partner within a country or across the region.

The IRIS GLOBAL team of specialists in Ecuador, the United States and other countries in Latin America offers a complete set of professional skills such as:

• Assessment of current capabilities and their compliance: establish the performance of regulations in one or more countries, and detection of strengths, opportunities, weaknesses and threats in the current regulatory approach.

• Develop product submission strategy in Latin America:  IRIS GLOBAL builds country-by-country strategies and integrate them into a cohesive and coherent strategy for the region. The importance of a regional strategy is to optimize the resources of our clients, as only a Macro vision allows us to proactively activate and find areas for improvement. (For example, optimization of labeling, development of a Master Dossier that minimizes risks of observations by Authorities and therefore delays, etc.).

• Develop product submission strategy:  IRIS GLOBAL works with commercial and development teams to assure Regulatory actions and activities are proactively taken into account in product development.

• Manage product life cycle: IRIS GLOBAL prepares filings and updates based on product life-cycle changes to assure ongoing compliance and market access.

• Prepare and manage dossiers through approval: IRIS GLOBAL prepares master dossiers, translate them into the local language, and submit to health authorities for approval.

• IRIS GLOBAL helps you to be ahead of the curve by learning about regulatory trends and changes before they happen.

• The importance of a regional strategy is to optimize the resources of our clients, as only a Macro vision allows us to proactively activate and find areas for improvement. (For example, optimization of labeling, development of a Master Dossier that minimizes risks of observations by Authorities and therefore delays, etc.).