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Regulatory Intelligence

Introduction

Life Sciences companies across the world require strong Regulatory support to make important decisions like expanding their product portfolio or to market their products across multiple geographies. En route, they face critical challenges while decoding local dossier requirements new guidelines, ingredient & claim analysis, labeling & packaging requirements, import regulations etc. In such scenarios, there is an undeniable requirement to ensure that companies are aware of these existing geo-specific regulations and also of any forthcoming guidelines to be published. Then it becomes essential that companies need authoritative Regulatory Intelligence(RI), which can address all the challenges accurately. We understand these importance’s and helps our customers to overcome this hurdles.

Scenario

Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output – e.g. outlining risks and opportunities – to the regulatory strategy. The process is driven by business needs and linked to decisions and actions.

Challenges for RI professional

Include Ever increasing growth of information Regulatory Authority transparency initiatives

  • EMA sharing information on medicines during various stages of MA process; meetings and workshops; other outcomes Regional differences
  • External regulatory environment across the Globe Information flow- reaching the right people in your company
  • Push versus pull of information