COMPANY CAPABILITIES
Company Capabilities
GxP Consulting Group provides services for Biotech/Pharma/Device based companies with customer-focused support and a skilled staff of employees.
Typical project support includes:
Validation
Validation Master Planning, URS, Risk Assessments, SOPs, IOQ, PQ, Media Fills, Computer System Validation/Part 11. Specializing in qualification planning, protocol generation and execution with deep experience mitigating issues and streamlining this process to improve timelines, cost and ensuring it is done right the first time.
Support Includes:
Manufacturing
Equipment Facility/Utilities
Laboratory Instruments
Shipping, Cleaning, Process, Media Fills
Engineering
URS, FS, DS, SDS, Commissioning Plan, Engineering Studies, DR/DQ, FATs, SATs, TOPs, Commissioning Protocols and Reports, Cycle Development, Process Characterization
Project Management
Project Coordination, Project Scheduling and Managing Timelines, Project Controls, Manage Project Execution, etc.
Quality Assurance
Data Integrity Assessments, Risk Assessments, Change Control, CAPAs, Deviations, QMS Planning and Improvement