Solution Overview

Simplify compliance with holistic regulatory solutions

The challenge: addressing conflicting demands

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The current environment for regulatory affairs in life sciences is a tough one. Companies are under pressure to manage a wide range of competing demands.

On one hand, they want to focus on value-added work and get rapid approval for new products. On the other hand, the work involved in maintaining and simplify compliance of existing products is mounting. They must keep up and comply with increasingly complex and time-critical regulatory requirements.

Efficiency is also top of mind. The mantra today is to do more with less by applying the right people and resources at the right time. To simplify compliance, this calls for agile teams – globally and locally – backed by the right training, that can flex to deal with peaks in regulatory submissions and high volumes of data. That is not always an easy bill to fill.

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These issues multiply when companies do not have the right processes and systems in place necessary to simplify compliance or promote effective regulatory solutions. Mergers and acquisitions often result in a mix of legacy technology and processes. Without harmonization, compliance and productivity can suffer because regulatory information, reporting, and analytics may be unreliable.

Industry leaders need to learn new ways to address these challenges to make regulatory affairs a highly efficient growth engine that concentrates on product development and strategic initiatives.

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