A structured License Application approach tailored to support your product, process, timeline and risk tolerance.

A License Application requires a detailed CMC package of information to support submission. The Drug Substance and Drug Product packages are tailored according to:

  • Key milestones
    • Pivotal study readout date
    • Clinical urgency and expedited status
    • Planned submission date
  • Material requirements
    • Clinical re-supply
    • Initial launch supply
  • Commercial supply strategy
    • Initial supply site
    • Subsequent supply site (if required)
  • Customer’s tolerance to risk

A step-wise approach is applied to ensure collaboration and Customer alignment throughout the CMC journey.

The CMC data package encompasses analytical development and method validation, small scale process characterization studies, GMP validation batches (PPQ batches), process validation studies and product-related analytical studies.

A combination of small scale and large scale experimentation is used to establish scientific evidence that a process is capable of consistently delivering quality products.

The key to success is experience, track record and expertise.
  • 100% License Application success rate in all our mammalian history
  • Regulatory support from 60+ team members aligned with manufacturing sites around the globe
  • Global regulatory expertise & support throughout the development life from early phase to post-approval/ lifecycle management
  • Draft of detailed CMC information sections with Customer review and eCTD ready
  • Timely post-submission responses to questions from regulatory authorities
  • Supported 45 approval inspections across the globe

Our regulatory experts can support you through the journey with:

  • Experience
  • Track record
  • Knowledge of the ‘what’ and the ‘how’

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