Enhancing Regulatory Compliance

Regulatory compliance is crucial in the pharmaceutical industry to ensure products meet the necessary regulatory standards for safety, efficacy, and quality. To stay ahead of this evolving landscape, pharmaceutical companies must prioritize efficient strategy planning, streamlined submissions, registration tracking, and effective communication with health authorities. By partnering with Orion, a recognized Market Leader for Regulatory Information Management (RIM) Solutions by Gartner, pharmaceuticals can leverage cutting-edge technology to enhance their regulatory processes, achieve faster time to market, mitigate risks, and build a stronger reputation in the market.

How we can help

Regulatory Information Management (RIM)
  • RIM Vision and Strategy
  • Review and re-design of RIM processes
  • Development process maps and narratives / SOPs
  • Adopting DIA RIM Reference Model
  • Leveraging RIM Analytics to improve decision making and efficiencies

Watch this on-demand webinar on how technology initiatives are helping life sciences companies transform their product registration process across multiple geographies.

Regulatory Information Management (RIM) Reference Model
  • RIM Reference Model Alignment Assessment Strategy
  • RIM Reference Model for due diligence prior to M&A
  • RIM Reference Model for RIM Implementation
  • RIM Reference Model for defining migration strategy

Read this report on the RIM Reference Model: Improving Efficiency, Compliance, and Interoperability.

Listen to our podcast and read the RIM white paper version 2.0 with Orion’s, V. “Bala” Balasubramanian sharing his thoughts about the reference model and its use cases. Version 3.0 coming soon.

IDMP Implementation
  • Performing gap assessment
  • Identifying IDMP data sources
  • Defining business process and developing regulatory procedures to align with EMA TOM
  • Implementing IT architecture and systems
  • Setting up data governance and data quality operations
Regulatory Intelligence
  • Regulatory Intelligence Assessment
  • Regulatory Intelligence Process Analysis/Design
  • ReALM® Regulatory Intelligence Platform
  • Regulatory Intelligence Automation

Watch this on-demand webinar on Managing Regulatory Intelligence with Cloud Technology

Learn more about the Regulatory Affairs Lifecycle Management Platform (ReALM ®), our cloud-based platform that transforms the regulatory value chain.

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