Regulatory Affairs

Chemistry, Manufacturing, and Controls (CMC)

Generating Regulatory Affairs Impact

As regulatory complexity increases across global markets, and growth through mergers and acquisitions is commonplace for many life sciences companies, CMC organizations are overwhelmed with the volume of activity. To meet the demands of the business, strategic resourcing has become a key component of the operating model. Genpact Pharmalink supports clients through all phases of the product lifecycle, from new product filing strategy to all aspects of lifecycle management.


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Genpact Pharmalink's unique Lean DigitalSM approach harnesses the power of Systems of Engagement (SoETM), Lean principles and domain expertise to help clients reimagine their regulatory affairs operating model, with flexible, expert CMC support across the regulatory affairs value chain. Our process expertise and technology-enabled services ensure clients benefit from enhanced efficiency, decreased cycle time, improved quality, and process standardization. Our solutions include:

  • CMC strategy: strategy and planning from product development to new product filings, relevant health authority meeting support and interaction, due diligence, site rationalization, and submission coordination
  • CMC authoring: Modules 2.3 and 3, NDA/MAA and IND/CTA, line extensions, dossier formulation/translation, and much more
  • Lifecycle submissions: License renewals, annual reports, support of government and hospital tenders, CPPs, legal entity changes, and ancillary document collection/compilation
  • Dossier review and compliance: Data review, dossier consistency, compliance audit, gap analysis and remediation, pre-approval preparation and pre-audit, due diligence assessment, and GMP inspection

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