OUR CAPABILITIES

GxP Consulting Group provides specialized consulting services for biotechnology, pharmaceutical, and medical device companies, offering customer-focused support and a highly skilled team of experts. Our goal is to streamline regulatory compliance, optimize processes, and ensure successful project execution.

🔹 Typical Supported Areas Include:

• Manufacturing

• Equipment, Facilities & Utilities

• Laboratory

• Warehouse / Temperature Controlled Units

Validation

We specialize in validation planning, protocol generation, and execution, with extensive experience in risk mitigation, process optimization, and cost-effective solutions. Our expertise ensures compliance while improving project timelines and efficiency.

✅ Capabilities include:

• Validation Master Planning (VMP)

• User Requirements Specification (URS)

• Risk Assessments & SOP Development

• Installation/Operational/Performance Qualification (IQ/OQ/PQ)

• Air Flow Visualization (Smoke Studies)

• Media Fill Support: Protocols, Risk Assessments, SOP Generation

• Shipping, Cleaning, and Process Validation

• Computer System Validation (CSV) & 21 CFR Part 11 Compliance

• Temperature Mapping Support and Temperature Mapping Equipment Rental

Engineering

Our engineering expertise ensures comprehensive system design, commissioning, and qualification to meet regulatory and operational requirements.

✅ Capabilities include:

• User Requirement Specification (URS), Functional Specification (FS), Design Specification (DS), and Software Design Specification (SDS)

• Commissioning Plans & Engineering Studies

• Design Review & Qualification (DR/DQ)

• Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), & Turnover Packages (TOPs)

• Commissioning Protocols & Reports

• Cycle Development & Process Characterization

Project Management

We provide strategic project management to ensure seamless execution and on-time delivery of critical initiatives

✅ Capabilities include:

• Project Coordination & Scheduling

• Timeline & Budget Management

• Project Execution Oversight & Controls

Quality Assurance

We help companies establish robust quality management systems to ensure compliance with regulatory standards and maintain operational excellence.

✅ Capabilities include:

• Data Integrity & Risk Assessments

• Change Control & Deviation Management

• Corrective and Preventive Actions (CAPAs)

• Quality Management System (QMS) Planning & Process Improvement