Regulatory Affairs

Regulatory Operations

Generating Regulatory Affairs Impact

Regulatory operations are challenged with achieving the global scale and flexibility necessary to meet steep staffing requirements. Success hinges on rethinking the operating model by adopting strategic resourcing and lean, technology-enabled processes. Genpact Pharmalink is the industry's leading global regulatory services provider, offering end-to-end regulatory operations services ranging from product registration to post-approval maintenance.


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Genpact Pharmalink works with organizations to transition towards a regulatory operating model that leverages advanced Systems of Engagement (SoETM), process and domain excellence, and scalable resourcing for improved compliance, faster speed to market, and value through greater efficiency. Tailoring a flexible service model to unique organizational needs, regulatory operations support can include technical staffing, project consulting, and sustainable, full-service outsourcing.

Services are provided by best-in-class, global regulatory operations centers of excellence, strategically situated in the United States (US), United Kingdom (UK), Latin America, and India. Deeply experienced teams enable cost-effective regulatory operations resourcing off- and near-shore, with onshore project management and 24-hour support capabilities. We support:

Submissions management

  • Submissions management
  • Publishing (eCTD, NeeS, eCopy, ACTD, Paper)
  • Submissions and QC validation
  • Health Authority dispatch

Document and data management

  • Data management
  • Document management
  • Submission readiness services

Ancillary services

  • Content conversion
  • Printing, local paper management/dispatch
  • Operations support (translation/literature search/training)

Life-cycle support

  • Clinical operations
  • Safety operations
  • Labeling operations

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