About 888 Pharmaceutical, LLC. Consulting company in Boise, United States
In 2012 the FDA stated its intent to drastically increase audits of pharmacy compounding facilities. In six months there have been 40+ citations issued; this is 40x more than the previous average of one citation per year. 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. If you have already been cited or are nearing non-compliance for a deficiency our staff can assist in agency correspondence and response preparation.
With over 25 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 and have assisted clientele in efficient and cost-effective filing.
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.
888 Pharmaceutical is a Global Regulatory Affairs Consulting firm with over 25 years experience in providing regulatory submission support for new and complex post- approval generic applications (ANDAs). We have successfully filed and supported new drug applications for small generic pharmaceutical manufacturers as well as fortune 100 pharmaceutical manufacturers.
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