GxP Consulting
Biologics / Cell & Gene Therapy
Innovative Solutions
Supporting the manufacture of complex biologics represents a third of our global business.
In a space with significant potential to address unmet patient needs, i-Pharm GxP is proud to partner with clients to bring tomorrow’s treatments into compliant, scalable manufacturing.
We have a proven track record supporting breakthrough, fast-track, and orphan drug (ODD) therapies, applying a quality-by-design approach that optimises GxP systems and manufacturing processes in line with modern regulatory expectations.
Our Technical Capabilities
We scope, staff, manage, and deliver business-critical project initiatives that underpin compliant and efficient manufacturing operations across the following areas.
Quality Assurance
- Root Cause Investigation Analysis and Corrective & Preventative Action (CAPA) design and delivery
- Quality Operations Oversight & continuous manufacturing support
- Supplier Quality Audit & Assessment
- QMS Assessment, Development & Optimisation
- Hypercare/Hypervigilance services (CMO/CDMO oversight)
- Lean Six Sigma, DMAIC, fishbone, 5-whys methodologies, ISO 9001 & GEMBA/process walk-downs
Quality Control
- Microbiology & Immunology Support
- Lab Event Workflow Analysis
- Assay Development & Testing
- Analytical Instrument Audits
- Environmental Monitoring
Audit & Remediation Services
- Inspection Readiness
- Mock Audits/ Audit Preparation
- Pre-Approval Inspections (PAI)
- Remediation Services
- Audits of Critical Utilities, Laboratories, Manufacturing/Production facilities, and Warehousing/storage areas
- Gap Analysis and Priority/Impact Action Plans
- Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
Commissioning, Qualification and Validation Engineering
- Commissioning, Qualification, and Verification Services
- Computer Systems, Process and Equipment Validation
- Facilities Engineering
- Process Engineering
- IQ, OQ, PQ
- HVAC/facilities, smoke studies, air balancing, temperature mapping, environmental monitoring
Computer & Control Systems
End-user optimization/harmonization, training, development, and implementation services for:
- QMS (Trackwise, eQMS, MasterControl, etc.)
- LIMS
- RIMS
- Labware
- MasterData
- KNEAT
- Netsuite
- Oracle ERP Cloud
- Johnson Controls, GE Digital, Siemens, Honeywell, Emerson Systems
AI / Machine Learning
- Automation System implementation and optimization services (Metasys, Rockwell, etc.)
- Bioinformatics and pipeline buildouts through machine learning deployment and architecture building
- Data Cleansing
- Cloud Migration
- Data and infrastructure scaling and buildout
Technical Writing / Medical Writing
- Technical documentation authoring, review, editing, and approval – SOPs, Work Instructions, Batch Record Review, etc.
- Grant writing, scientific writing, editing/copy editing. Regulatory documentation, SOPs, CERs, CSRs, MDD/MDR, Submissions
- Writing protocols, clinical study reports, investigator brochures, and IND components
Construction
- GMP Construction Management
- Construction quality management
- Contractor and vendor management (Owner’s Representative)
- Construction and vendor turnover package (CTOP/VTOP) planning and execution
Project Management & PMO
- Capital project management from concept to handover
- Cost engineering, scheduling, and risk management
- Integrated master scheduling across construction, CQV, and operations
- Governance, reporting, and stakeholder management
- Change control, forecasting, and project controls
Trusted Partners
i-Pharm GxP is purpose-built to support the unique challenges of Biologics manufacturing. We help partners navigate evolving and ever-increasing regulatory expectations, overcome talent constraints through focused training and development, and deliver resilient internal and outsourced manufacturing supply chains supported by strong CMC strategy planning.
From end-to-end CAR-T manufacturing capability build-outs through to successful Biological License Applications, i-Pharm GxP is a trusted Biologics partner.
