ARx Quality & Regulatory Support

The ARx quality management team is comprised of pharmaceutical industry specialists dedicated to ensuring compliance with the relevant monographs, agencies and adherence to Good Manufacturing Practices (GMP). Product safety, efficacy and quality are assured at the ARx manufacturing facilities and all supply chain partners during each step of the development and commercial process.

The ARx quality team supports our development and commercial partnerships by providing oversight of quality control, assurance of documentation completeness and accuracy, as well as certifications for global filings.  We conduct on-going monitoring of GMP commercial manufacturing processes to assure a continuous state-of-control. Our quality department includes supplier quality engineers, quality assurance, quality control, product test & release and these capabilities:

Quality and Regulatory Support
FDA Registered and cGMP Compliant ARx facilities have been audited and site approved by the FDA and other global agencies.
CMC Filing Support Experienced in providing ANDA, NDA filing support with the FDA, as well as global branded and generic filing support.
Raw Material Support Packages Establishment of specifications and certifications according to global compendial requirements.
Supplier Quality Management Assured at each level of the supply chain.
Product Development Report for submission Authorship of product development report for formulation and process development utilizing QbD principles.
Product release and certification Test and release of bulk intermediate and finished product.