GxP Consulting
Biologics / Cell & Gene Therapy
Innovative Solutions
Supporting our partners to develop and manufacture complex biologics represents a third of our global business.
With huge potential in this space for innovative solutions to unmet patient need, i-Pharm GxP is proud to assist clients with spearheading the development of tomorrow’s treatments.
We have a proven track record supporting breakthrough, fast-track and ODD therapies, ensuring a quality-by-design approach that optimises GxP systems and processes in-line with modern regulatory demands.
Our Technical Capabilities
We scope, staff, manage and deliver business-critical project initiatives for clients with capabilities in the following areas.
Quality Assurance
- Root Cause Investigation Analysis and Corrective & Preventative Action (CAPA) design and delivery
- Quality Operations Oversight & continuous manufacturing support
- Supper Quality Audit & Assessment
- QMS Assessment, Development & Optimisation
- Hypercare/Hypervigiliance 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 (Trackiwse, 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
Regulatory Affairs
Working experience with Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, and PMDA supporting:
- Investigational New Drug (IND)
- New Drug Application (NDA)
- Abbreviated New Drug Application (ANDA)
- Orphan Drug Designation (ODD) and
Biologics License Applications (BLA)
Investigational Device Exemptions (IDE)
510 (K) submissions and
Pre-Market Approval (PMA)CMC strategy management and delivery
Clinical Operations
- Functional Service Provider (FSP)
- Clinical Trial Oversight & Management
- Clinical Operations
- Biostatistics
- Data Management
Trusted Partners
i-Pharm GxP is built to support the unique challenges in this space. Our partners benefit from our agility in supporting the evolving and ever-increasing expectations from regulators, our human capital strategies that mitigate the challenges of talent scarcity through investment in training and development; and our ability to support both internal and out-sourced manufacturing supply chains through detailed CMC strategy planning.
From developing end-to-end CAR-T manufacturing capabilities to delivering successful Biological License Applications, i-Pharm GxP is a specialist Biologics partner you can rely on.
