Consulting

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
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