GXP Consultants, Inc.

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:

PHARMACEUTICALS
BIOLOGICS / BIOPHARMACEUTICALS
BIOTECHNOLGY-DERIVED PRODUCTS
MEDICAL DEVICES AND DIAGNOSTICS
ACTIVE PHARAMCEUTICAL INGREDIENTS (API)

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.

	SERVICES Overview Process & Facility Construction FDA Compliance Regulatory Submissions Calibration Validation & Testing IT Systems Safety & Environmental Risk Clinical Development Legal Finance PRODUCTS Process & Production Equipment Laboratory & Facility Equipment EDMS (E-Documentation) PROJECTS MANAGEMENT LINKS CONTACT MEMBERS
	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: PHARMACEUTICALS BIOLOGICS / BIOPHARMACEUTICALS BIOTECHNOLGY-DERIVED PRODUCTS MEDICAL DEVICES AND DIAGNOSTICS ACTIVE PHARAMCEUTICAL INGREDIENTS (API) 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.	13681 Newport Avenue Suite 8-620 Tustin, CA 92780 (714) 325-8896