Quality & Regulatory

Althea has an impressive and successful track record in regards to our regulatory history. Althea's manufacturing facilities have been FDA inspected in 2005, 2008, 2011 (2), 2012, and 2013. 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 manufacturing in California. Althea hosts an average of 6 client audits a month, and has had over 30 Qualified Person (QP) inspections to date from countries such as Germany, UK, Belgium and France. Dependent on client progress, Althea expects EMA commercial inspections in 2013. 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 ®

Althea is always eager to help you with your regulatory submissions, agency meetings and audit support. We look forward to working with you.

Why
Althea?

Biologics Manufacturing

Biologics Manufacturing

While the experience of Althea’s Biologics Manufacturing group assures that your bulk drug substance will be successfully produced in the most efficient way possible, the integration of the downstream manufacturing steps means that you have just one partner to work with and manage logistics of product and communication.  This all reduces the time, cost, and risk of drug development.  Learn More

Protein Analytics

Protein Analytics /
Stability Testing

Any development program must have the appropriate analytical methods in place to ensure the integrity of the protein through production.  Having biologic manufacturing and analytical development working hand-in-hand and at a single partner will greatly shorten the time required to produce cGMP product.
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Aseptic Fill and Finish

Aseptic Fill
& Finish

Forget about shipping valuable API from facility to facility and qualifying additional vendors.  At Althea, after producing and formulating your API, we can fill your clinical or commercial drug product into vials or syringes.  This enables us to release your batches much sooner that you would can expect after shipping material across multiple service providers.  Learn More