ARS works with large and small companies and is accustomed to managing large complex programs, which involves different functional areas, as well as small projects.  We specialize in providing high-quality services and customized solutions that not only increase a program or project’s scientific foundation and regulatory compliance, but also improves the efficiency and effectiveness of an organization’s operation.

ARS can provide assistance with the following topics:

  • Establishment of a quality management system
    • Documentation control
    • Change control
    • Corrective action preventive action (CAPA)
    • Deviation and failure investigations
    • Recalls
  • Analytical method development and validation, and laboratory testing
  • Product development support
    • Establishment of product specifications
    • Stability studies
    • Drug Master Files (DMFs)
    • Chemistry, manufacturing and controls (CMC) documentation
  • Food Safety Modernization Act (FSMA) compliance
  • Expert witness services
  • Support after receipt of a FDA Form 483 or warning letter