Keys to a Successful Rapid Commercial Launch

In manufacturing, pharmaceutical companies’ drugs are produced in hopes to save patients as fast as they can.  It is a “race to the finish” pharmaceutical online stated.  Getting the drug products produced and sent out to patients as fast as possible is every manufactures goal.

The third highest number of drug approvals in over twenty years was in 2019.  48 drugs were approved by the FDA that year.  Of these 48 drugs, 17 were designated as fast track, 13 as breakthrough therapies, 28 were priority review and 9 were accelerated approval.  With all of these drugs approved, manufacturers need to produce as many as they can, as fast as they can—in order to help the patients that need these drugs.

A rapid launch must follow regulatory approval that allows for both the sponsor and the manufacturing partner to work together to supply medication to patients in minimal time.

There are many factors to a rapid launch, including:

  • Timeline
  • Understand key inputs and relationships
  • Identify risks & create mitigation plans
  • Provide daily updates
  • Open communication
  • Understand roles

Within these rapid launches, many challenges could occur.  Delays, validation, failures and execution issues.  InQuest Science’s Identifier System is built to help prevent these issues, helping with workflow and speeding up the process.  There are multiple validation requirements needed for any product imported into the system, there are clear requirements needed for every data import and there is a full audit history log for all data imported into the system.  This system helps trace defects faster, leading to less recalls.  This Identifier System will help many manufacturing companies with rapid commercial launches.

Read the full article published by Pharmaceutical Online 


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