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Quick scan & GAP analysis

What are the risks associated with enlarging the business to new markets?
Is the manufacturing site ready for an inspection?
Is it possible to file a new drug application earlier without extensive development work in order to be the first on the market?

These are typical questions in the boardroom of today’s pharmaceutical companies which can be addressed by using GAP analysis / Quickscan tools.

These tools provide within a short period of time essential information to the decision makers of a company. Based on the acquired information the decisions makers can understand business risks, prioritize business needs and if needed decide whether identified gaps need to be addressed or that associated risks are acceptable. 

How can Progress-PME help you?

  • Do you want an independent and quick review of your compliance status or the status of your drug development project?
  • Do you want to know whether your company complies with the fast evolving regulatory requirements with respect to process validation and/or cleaning validation?
  • Do you want to know whether your company is ready to file a new drug/biologic license application? Do you want to know whether you can reduce the lead time of your release process? Do You want to know the current status of your QC department?

Progress-PME offers experienced specialists and consultants who can help you to identify gaps and thereby business risks within a short period of time. Based on their extensive experience, Progress-PME can perform a GAP analysis and can advise you whether the identified gaps are acceptable or require actions. This can help you to allocate resources on the priority activities and design efficient budgets by taking into account the main concerns.

We offer the following GAP analysis / Quickscan tools:

Executive services:

  • CMC Quickscan (time-to-market)    
  • Compliance Quickscan (license-to-operate)
  • Lean Quickscan

Professional services

  • Cleaning validation Quickscan
  • Engineering Quickscan
  • QC Quickscan
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