Stability for ANDA Filing

At FreeThink, we have used our ASAPprime® software in conjunction with stability studies either in our laboratories or at the sponsor generic company (or a combination of the two) to successfully speed the process of getting ANDA’s filed.  Here’s how:

  1. Conduct an ASAPprime® trial on prototype of drug product and comparator, non-GMP (3-6 weeks)
  2. Assign 12-month use period based on >95% confidence that product will remain in specification and demonstrating equivalent/superior performance to comparator
  3. File INDA using ASAPprime® models
  4. Place product on traditional (ICH) stability program
  5. Use combination of ASAPprime® modeling and ICH data to justify ANDA

 

At FreeThink, we have the experience to work with internal regulatory leadership to develop an appropriate strategy for getting generic drug products approved.  We can also directly conduct the support studies in our laboratories.