It is now more important than ever to ensure your facility is audit ready. Our specialists have extensive experience in FDA audit preparation, support, and risk-mitigation. Our staff can assist in agency correspondence and response preparation.
How we can help:
With over 35 years’ experience in providing regulatory submission support for new and complex post-approval generic applications (ANDAs), our seasoned consultants have seen it all and know how to get it done right, the first time. We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical heavyweights. Our senior consultants are considered thought leaders in generic filing strategy.
CMC submission publishing can be a tedious, time-consuming process. Preparing submissions in an eCTD format may not only drastically decrease the preparation time of future submissions but decreases agency review time and future publishing costs. Not ready to submit in full eCTD? No problem, our staff is experienced in hybrid submissions to simplify the eCTD transition.
Interested in a proposal? Connect with us Today.
Contact Details
1.909.576.6424
888 Pharmaceutical, LLC.
222 N. 13th St. Suite 200
Boise, Idaho 83702