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

Quality Assurance

  • Root Cause Investigation and Corrective & Preventative Action Design and Delivery 
  • Quality Operations Oversight & Continuous Manufacturing support 
  • DMAIC, RCA, GEMBA / process walk-downs, 5-whys, fishbone methodologies
     
Quality Control

Quality Control

  • Environmental Monitoring
  • Clean Rooms design and engineering for laboratory and manufacturing facilities
  • Microbiology/Immunology
  • Assay Development and Testing
     
QMS Assessment, Development and Optimisation

QMS Assessment, Development and Optimisation

  • eQMS, Trackwise, MasterControl
  • ISO 9001
  • Six Sigma
  • Gap Analysis, Risk Matrix and prioritised impact/action plans
     
Commissioning, Qualification and Validation Engineering

Commissioning, Qualification and Validation Engineering

  • Computer Systems, Process and Equipment
  • Facilities Engineering 
  • All aspects of aseptic processing and sterile injectable production.
  • IQ, OQ, PQ 
  • HVAC/facilities, smoke studies, air balancing, temperature mapping, environmental monitoring 
     
Regulatory Submission Preparation

Regulatory Submission Preparation

  • BLA – Biological License Applications
  • Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
     
Inspection Readiness

Inspection Readiness

  • PAI 
  • Audits of Critical Utilities, Laboratories, Manufacturing/Production facilities and Warehousing/storage areas. 
  • Gap Analysis and Priority/Impact action plan 
     
Audit Response & Remediation

Audit Response & Remediation

  • Across the Biotech, Pharma and Medical Device Industries (GLP, GCP, GMP, GxP)    
  • Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
     
Technical Writing / Medical Writing

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
     
AI / Machine Learning

AI / Machine Learning

  • Data and Infrastructure scaling and build out
  • Bioinformatics and pipeline buildouts thru machine learning deployment and architecture building.
  • Data cleaning and data migration to the cloud. Ensuring proprietary data is cleaned, easily accessible, and can be fed into the ML model and algorithm.
     

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.
 

consulting services

Our Markets

Our teams of SME consultants work in partnership with our clients to enable the compliant, efficient supply of niche-regulated products to patients across the global life sciences space. 

Sterile / Aseptic Manufacturing.

With a 15-year history of working directly with the world’s leading Sterile and Aseptic Manufacturers as a specialist, i-Pharm GxP has a reputation for both trust and long-term value. 

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Medical Devices & Combination Products.

We offer specialist, tailored support to Class I, II, and III Medical Devices and Combination Products, ensuring their safe and reliable delivery to patients. 

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