Pre-Registration Services

Overcome the complexities of the registration process with the support of our proactive problem solvers.

Ensuring Successful Transition from Clinical to Commercial

As your product advances from early phase to later phase trials, our project team expands to include subject matter experts from our Tech Transfer team that will work with you ahead of registration to evaluate and optimize your process to ensure that your end with a robust commercial process.

As your dedicated CDMO partner, we can help you define your control strategies for process validation, as well as understand your critical process parameters and design space before registration .

Understanding Your Processes

Late-stage development is critical to registration readiness and commercialization. But time, budget, and API constraints can present challenges when evaluating each stage of your process.

Our experts take a risk-based assessment approach to late-stage development that ensures pre-registration testing and data collection to evaluate process robustness and uses testing that mimics validation criteria.

Our pre-registration service helps to:

  • Validate your processes
  • Test the scalability of processes
  • Perform risk-based assessments
  • Determine any critical studies required using historical data

See how we’ve helped companies like yours in their pre-registration journey

Explore our case studies

Commercial Equipment

We use best-in-class equipment and continually invest in our equipment train so that we can offer solutions best mapped to meet your scale and needs. Offering guidance on equipment for pre-registration studies ensures appropriate scalability and a long planning window to ensure that your commercial manufacturing process is robust.

Get In Touch

Do you need a partner that can solve your most pressing novel oral solid dose challenge?

Talk to Metrics.