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 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

Quality Control

  • Microbiology & Immunology Support
  • Lab Event Workflow Analysis
  • Assay Development & Testing 
  • Analytical Instrument Audits 
  • Environmental Monitoring 
Audit & Remediation Services

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 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

Computer & Control Systems

End-user optimization/harmonization, training, development, and implementation services for:

  • QMS (Trackiwse, eQMS, MasterControl etc)
  • LIMS
  • RIMS
  • Labware
  • MasterData
  • Netsuite
  • Oracle ERP Cloud
  • Johnson Controls, GE Digital, Siemens, Honeywell, Emerson Systems
AI / Machine Learning

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 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

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

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.

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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Scope a project with i-Pharm GxP