Regulatory Affairs

Regulatory Information Management (RIM)

Generating Regulatory Affairs Impact

In an era of increasing complexity in global regulations, commercial pressure to expand into newer markets and with the impact of generics, enterprise-standard regulatory affairs information is pivotal for compliance, market readiness, and cost effective growth. However, a fragmented and sub-optimal system landscape, inefficient data management practices and the effects of mergers and acquisitions can impede operational efficiency and decision making, which affect business agility.

Solutions

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Genpact Pharmalink's unique Lean DigitalSM approach helps align regulatory information management strategy, operations and technology to business outcomes with an unbiased approach that combines the power of process-centric digital technologies, design thinking methods, Lean principles and domain expertise. Genpact Pharmalink provides proven solutions that capture, maintain, and deliver high quality regulatory information to increase productivity, reduce time to market, and ensure compliance for our clients. Our information management solutions include:

  • Regulatory information management strategy: including evaluating current capabilities against industry best practices (operating models, processes, data, and systems), mergers and acquisitions/divestitures planning and strategy, and the development of roadmaps and business cases
  • Process re-engineering: our unique combination of regulatory and process expertise, based on our innovative Smart Enterprise Processes (SEPSM) methodology, has successfully completed over 5000 process transformations for our life sciences clients
  • Information architecture and analytics: new regulation readiness, including ISO IDMP and UDI to deliver master data management architectures that maximize existing technology investments and connect legacy data silos. Advanced analytics capabilities combined with regulatory domain expertise pool historic and current data to derive new insights to transform the business decision-making process.
  • Implement and monitor: program and project governance, master data management, data migration, training, system validation, and audits

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