FDA Compliance & Quality Systems

The demonstrable compliance to FDA regulations and the effective implementation and management of Quality Systems is a pre-requite to product licensure. GXP Consultants' highly experienced staff offer a complete range of Quality Assurance and Regulatory Compliance services for the pragmatic implementation of Total Quality Management. These services are applicable to industries involved in the manufacture of:


GXP Consultants offer a complete range of GXP Quality Systems services tailored to both the clients' needs and global regulatory expectations. GXP Consultants Quality Systems capabilities are wide ranging from full on-site functional support to manufacturing and testing operations to the integration of specific quality activities and services; these GXP Quality Systems Services include, but are not limited to:
  • Development and implementation of Core Quality Systems, for example, Change Control, Training, Planned Preventative Maintenance Schedules, Validation, Documentation, Out-of Specifications, etc.
  • Auditing Services including GMP, GCP, GLP and QSR Audits, GAP Analysis, Vendor Certification and Mock FDA Inspections
  • "War Room" management during FDA inspections
  • Post-Inspection Quality Systems Review and Improvement programs
  • Development of a CAPA (Corrective and Preventive Action) computer based program
  • Addressing Deviation Investigations and Reports
  • On-site GMP, GCP and GLP Training including Training the Trainer
  • Preparation and implementation of Standard Operating Procedures (SOPs) and Validation Protocols
  • Preparation and review of Batch Records
  • Providing Annual Product Review Services and data Trend Analysis
  • Development and Implementation of product labeling and packaging programs
  • Development of justifiable specifications for the evaluation of in-process and final product testing

Further details of specifically tailored Quality Support functions are available following a preliminary discussion.

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