Quality & Regulatory
Althea has had an impressive and successful track record in regards to our regulatory history. Althea’s manufacturing facilities have been FDA inspected in 2005, 2008, 2011 and 2012. In addition, we hosted a successful PAI by CBER in April 2011 resulting in Commercial Licensure in June 2011. We are also current on our Food and Drug Branch (FDB) License, which is required for clinical manufacturing in California. Althea hosts an average of 6 client audits a month, and has had over 27 Qualified Person (QP) inspections to date from countries such as Germany, UK, Belgium and France. Dependent on client progress, Althea expects EMEA commercial inspections in 2012. The frequent audits and inspections at Althea help hone the quality of Althea’s programs and further ensure the compliance of FDA’s cGMP regulations. Our Regulatory support team has authored numerous IND /NDA/BLA/eCTD submissions and is ready to help with your clinical filings and commercial launch. Althea utilizes state-of-the art cGMP validated Part 11 compliant software programs:
- Blue Mountain RAM Cal Man®
- BMS Seivers®
- AuditUtopia®
- Master Control®
- Novatech®
- Chromeleon HPLC ®
