REGULATORY COMPLIANCE

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.).

A professional team ready to assist you
REGULATORY COMPLIANCE

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.

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REGULATORY INTELLIGENCE

IDENTIFY, CLASSIFY AND COMMUNICATE

The Drug Information Association (DIA) defines Regulatory Intelligence as: The act of gathering and analyzing publicly available regulatory information.  This includes communicating the implications of that information, and monitoring the current regulatory environment for opportunities to shape future Regulations, guidance, Policy, and legislation.

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in - country representation

Globlocal®, aims to work globally and act locally.

COMMERCIAL CONSULTANCY

The commercial consultancy detects the strengths of a company to maximize them; it also detects weaknesses to eliminate them, and elaborates strategies and tools a company needs to improve productivity and sales force.

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