Regulatory Support with ASAPprime®

ASAPprime® helps make regulatory submission packages more robust by providing scientific rationale for decisions.  In some cases, ASAPprime® study data has been successfully used in place of traditional long-term ICH studies for regulatory filings.  While some countries have refused to consider the Accelerated Stability Assessment Program (ASAP), others have been more receptive.  In general, this approach has been used to help speed new drug candidates into clinical trials more quickly.  In many cases, contingency samples of clinical supplies were placed in chambers for analysis with data available for regulatory queries.

FreeThink successfully works with both large and small companies to increase the initially granted shelf-life at the time of registration for new products.  In fact, one international pharmaceutical company recently reported that it was granted a three-year shelf-life at launch for a new drug product in the EU, using ASAPprime® analysis and just three months of traditional ICH data (with commitment for ongoing monitoring).

 

ASAPprime® data can also be used to:

  • Contribute to regulatory filings as part of product understanding and QbD filings
  • Justify acceptance after shipment or storage excursions
  • Validate acceptability of generic versus originator drug products

 

Whether you are a first-time ASAPprime® user or a long-time customer, FreeThink can help with your regulatory strategy, and ensure a scientifically robust submission package based on ASAPprime® studies and data analysis.

 

 

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