Product/Service

FDA Regulatory/Quality Serivces

Source: Process Safety & Reliability Group Inc. (PSRG)

Through in-house staff and an affiliation with other professionals
Through in-house staff and an affiliation with other professionals, PSRG strives to provide the highest quality services to the Medical Device, Pharmaceutical and related industries in specialized areas of Regulatory Affairs and Quality Assurance including:
  • cGMP Audits
  • Establishing Validation Plans and Test Protocols
  • Vendor / Supplier Audits and Inspections
  • SOPs (writing / revisions)
  • FDA Inspections / Investigations
  • Regulatory Compliance and Guidance
  • GMP Training
  • Import / Export Requirements
  • Product Submissions / Registrations
  • Clinical Studies
  • Good Laboratory Practices (GLPs)
  • Product Labeling
  • International Regulatory Considerations / Issues
  • ISO 9000 Issues

Process Safety & Reliability Group Inc. (PSRG) , 9114 Rhapsody Lane, Suite 1000, Houston, TX 77040-2515. Tel: 713-849-9460; Fax: 713-849-4326.