Navitas Life Sciences

Providing Regulatory Affairs support to manage Life Cycle Maintenance Submissions for a mid-sized biopharma

Our client, a mid-sized biopharmaceutical company headquartered in the US, had recently acquired 8 marketed products and were seeking a partner to support them in the management of their Life Cycle Maintenance Regulatory Submissions. They needed to quickly deliver to the US FDA but did not have an internal Regulatory Affairs team to support the required activities.

Read our latest case study and learn how we provided a dedicated Regulatory Affairs team that collaborated closely with our client to support and manage their Life Cycle Maintenance submissions. Effective communication and a well-defined project plan and process flow has seen our client benefit from:

  • 3 First-Time-Right BLA Life Cycle Regulatory Submissions
  • 100% adherence to submission timelines
  • 0% technical rejection from the US FDA

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