Lifecycle Management

G&L has extensive experience in performing post-approval license maintenance activities on a global basis. We have over 25 years’ experience in conducting post-approval license maintenance activities across all product types and markets.

Whether for specific licences, 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. Examples include:

  • Variations
  • Amendments/supplements
  • Product licence renewals
  • Annual reports
  • Line extensions
  • Urgent safety restrictions
  • Artwork and labelling
  • Technical authoring
  • Submission management and publishing
  • Expansion into new markets
  • Regulatory intelligence
  • Local submission support

G&L’s expert services

The outsourcing of these activities allows our clients to focus internal resource on those regulatory activities associated with 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.

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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