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Regulatory Compliance and Quality

Inspection Record

Federal and Statewide Licenses/Submissions

Quality Management

Althea maintains an impressive and successful regulatory track record. We maintain this impeccable track record using internal audit teams, regulatory agencies and customer inspections. Althea hosts 6 client audits a month and has had 48 Qualified Person (QP) inspections from countries such as Germany, UK, Belgium, and France.  We have successfully completed 11 drug approval inspections (6 onsite/ 5 desk) covering applications in the US, EU, Japan, Taiwan,Canada and Turkey indicating our drug product manufacturing processes, quality control testing and overall quality systems are in compliance with GMP requirements for all commercial filling lines.  Our processes and procedures are in compliance with European cGMP standards and FDA guidelines

Frequent audits and inspections refine the quality of our programs and further warrant the compliance of FDA’s cGMP and EU regulations. Our Regulatory support team has authored numerous IND/NDA/BLA/eCTD submissions and is ready to help with your regulatory submissions, clinical filings and commercial launch.

cGMP validated Part 11 compliant software programs:

  • Blue Mountain RAM Cal Man® for equipment and facility management
  • Building Management System Siemens®
  • AuditUtopia® for audit management
  • MasterControl® for quality systems management
  • Novatech® for management of stability program
  • Chromeleon HPLC® for GMP testing
  • QAD ERP for GMP raw material management
  • MODA for tracking and trending of environmental monitoring data

Althea’s Approach to Regulatory Excellence

  • Continuous improvement philosophy- trending, quality metrics, management review
  • PDA, ISPE Leadership assures leading-edge policies
  • Quality policies, standards and well-defined SOPs in place
  • GMP qualified vendors – reduces material procurement risks
  • Dedicated staff for internal audit compliance programs
    cGMP training programs in place
  • Constant inspection from customers and regulatory agencies
  • Multinational Compliance Program – Maximizes Clinical Flexibility
    Timely response to any observations
  • Internal Calibration, Validation, QC Chem, QC Micro, Doc Control
  • Work with a highly trained and experienced staff
  • Transparent communication with customer
2005 Announced FDA inspection
2008 Unannounced biennial inspection
2011 CBER PAI
Unannounced FDA inspection
2011 Two unnanounced FDA inspections
2012 Unannounced FDA inspection
2013 Two unannounced FDA inspections
2013 PAI
2014 European GMP inspection
2015 Three unannounced FDA inspections
2016 Turkey Ministry of Health GMP Inspections

Federal and Statewide Licenses/Submissions

  • CA FDB “Drug Manufacturing License”
  • Type V Drug Master File “DMF” CDER
  • Biologics Manufacturing File “BMF” CBER
  • Commercially approved for drug manufacturing with FDA
  • EU GMP Certificate issued by MHRA for quality control testing
  • GDUFA, Self-Identification with FDA
  • PMDA Codes Received for Facility Accreditation

Althea’s quality management system focuses on continuous improvement. We accomplish this through routine reviewing and trending of operational metrics with the senior management team and developing actions to drive optimization of processes. We are proactive in our communication with regulatory and industry organizations in regards to industry improvements and establishing policies. We take a collaborative audit approach with our clients and encourage feedback and suggestions.

We strive to provide our customers with a strong yet flexible strategy and show our customers that we are inspection ready at all times. This approach nurtures open communication and allows us to maintain a culture of transparency.

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