Regulatory Open Forum

 View Only

  • 1.  Translation Services

    Posted 15-Apr-2016 17:35
    I have a question for the group:  If your company uses a CMO in another country, how do you handle the translations?  Does the CMO provide fully translated, QA certified English translations?  Or do you use a service?

    I am looking for thoughts on economical ways to ensure we are fully compliant with the regulations, especially since this is now becoming a Refuse-to-File issue for ANDAs.

    Thanks,
       Lisa