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
Ataqua Regulatory Services LLC 