Regulatory Affairs

Regulatory Operations

Generating Life Sciences 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 works with organizations to support all aspects of their regulatory operations and transition to an operating model that provides scalable resourcing, improved compliance, faster speed to market, and value through process and cost-efficiencies.

Solutions

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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. Leveraging our global regulatory operations teams, and capabilities in process and technology, our skilled professionals work closely with clients to design and run holistic regulatory operations solutions. Tailoring a flexible service model to unique organizational needs, regulatory operations support can include technical staffing, project consulting, and sustainable, full-service outsourcing.

We support:

1. Submissions management

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

2. Document and data management

  • Data management
  • Document management
  • Submission readiness services

3. Ancillary services

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

4. Lifecycle support

  • Clinical operations
  • Safety operations
  • Labeling operations

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 nearshore, with onshore project management and 24-hour support capabilities.

Impact

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