AQS is able to efficiently guide clients to approvals for FDA and EU regulatory agencies with:

  • FDA/EU style audits to CFR Human Drugs, Biologicals, and Devices etc.
  • cGMP and company wide compliance upgrades for FDA and EU standards
  • Expert guidance in the preparation for regulatory and pre approval inspections (PAI) and site audits
  • Assessment of current levels of GMP and Compliance to FDA and EU standards
  • Recommendations and strategies to raise the level of GMP Compliance

In the area of Quality Assurance, AQS can assist your organization in the development of practical and effective quality management systems.

  • Internal audit program reviews targeting critical process control points and GMP weaknesses
  • GMP/GLP audit program design for compliance and manufacturing control
  • Risk management assessments for QA/QC for effective resource utilization

Establishment of comprehensive QA and manufacturing improvement programs, as well as assessment of GLP programs.

GMP Design Reviews

AQS is able to offer a GMP design review service covering the following areas:

  • Facility
  • Services
  • Utilities
  • Process Water
  • Materials Flow
  • Personnel Movement
  • Process Flow
  • Product and Materials Storage
  • Surface Finishes

Abbreviated New Drug Application (ANDA)

AQS provides guidance and assistance for the Abbreviated New Drug Application process (ANDA).