90% reduction in time to deliver pharma dossiers

viabl.ai helps pharma companies review drug dossiers in a fraction of the time, speeding up approvals and reducing operational costs.

Lengthy dossiers are slowing down pharma product approvals

5 days

review time for each dossier


Pharmaceutical companies are required to submit lengthy dossiers to health authorities (HA) to obtain approval for the distribution of their products within a certain geographical region. 

This is challenging on a number of levels. 

  • Complex and varied. Compiled throughout the drug development and clinical trial process, dossiers describe active ingredients, manufacturing processes, manufacturers and their premises, clinical trial results and more, and their requirements can vary by country or region. 
  • Error-prone. With close to ~700 data points to review, either for presence, correctness or both, there is high potential for human error. 
  • Costly and laborious. Reviews are a time-consuming, tedious task conducted by highly-paid (and qualified) scientists, taking approximately five days per dossier. 
  • Repetitive. Dossiers must be updated in the event of alterations, such as a change of manufacturer or manufacturing process and resubmitted for approval on a regular basis for renewals. 
  • Delayed approvals. Where missing or incomplete information is found, the HA will revert back for additional info or clarification, delaying approval.

Reducing dossier errors and accelerating approvals with Decision Intelligence

0.5 days

per dossier review with viabl.ai


A company’s ability to manage the lifecycle of a dossier accurately and efficiently impacts its ability to get to market quickly and maintain the required approvals needed to continue supplying its product. 
viabl.ai is the Decision Intelligence platform that embeds AI into the dossier review process, integrating with your data and expertise to accelerate go-to-market for your products. 

Operating either on-premise or in the cloud, viabl.ai can extract the information from dossiers and rapidly check the ~700+ data points for omissions and by leveraging an LLM, for correctness. 
Tailoring its output to the nuance of each case, viabl.ai can apply variations to checks based on the regional health authority to which the dossier in question is to be submitted. The results of this automated review can then be output to a scientist for final review, or to a manager where required. 
Moving forward, viabl.ai also leverages the decision data from each case to create insights into factors that increase the chance of success, allowing businesses to identify regional best-practices and adapt future submissions accordingly.



  • Increased likelihood of obtaining HA approval on first submission.
  • Reduced likelihood of errors or omissions leading to HA queries and delayed approvals.
  • Reduction in cost of dossier review, from five days’ Scientific Review down to approx. 0.5 days, with further cost reductions from lower rework/follow-up effort.
  • Easier to access new, previously untapped markets due to the reduced cost of meeting alternative HA requirements/standards.
  • Maintained rules and checks with a viabl.ai dashboard for updates whenever local legislation or regulation changes. 

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