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Lifecycle Management

G&L has extensive global experience of conducting post-approval license maintenance activities across all product types and markets.

Whether for specific licenses, markets, regions or entire portfolios, G&L is expertly placed to maintain and enhance our clients’ medicinal products, providing tailored regulatory intelligence and strategy, technical authoring, subject matter expertise, eCTD publishing and local submission services.

G&L’s expert services

The outsourcing of these activities allows our clients to focus internal resource on those regulatory activities associated with the early stages of the product pipeline and revenue-generating opportunities.

Our range of expert Lifecycle Management services provides confidence that the successful upkeep and regulatory maintenance of product licenses is assured, and that each product continues to be current, compliant and well-positioned for ongoing success.

Our services include:

  • Variations
  • Amendments/supplements
  • Product license renewals
  • Product launch support
  • Annual reports
    • IND/NDA/BLA
    • DSUR
    • DMFs
  • Line extensions
  • Urgent safety restrictions
  • Artwork and labeling
  • Technical authoring
  • Submission management and publishing
  • Expansion into new markets
  • Regulatory intelligence
  • Local submission support
  • Drug (and Establishment) Listing
  • New market expansion licensing
  • Post-approval
    • Line extensions (e.g. efficacy supplements, new dosage form)
    • SUPAC
  • Structured Product Labeling (SPL)
  • Artwork and Labeling
    • Ad/promo review and submission

Contact us today

For more information on Lifecycle Management, please fill in the form and we will respond to you as soon as possible.

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