Services
GxP Consulting
i-Pharm GxP
Life Sciences Consulting Services to scope, staff, manage, and deliver GxP projects across North America, Europe, and the Asia-Pacific.
With over 15 years of experience delivering business-critical project solutions that underpin compliant and efficient manufacturing, we work with you to scope your requirements, identify risks and opportunities, and agree on clear milestones for successful delivery.
Every engagement is governed by a tailored Scope of Work (SOW), providing a purpose-built roadmap aligned to your specific needs.
Previous engagements include:
- Validating aseptic manufacturing equipment, processes, and systems
- Implementing a new gLIMS and MES
- Responding to time-critical external audits at manufacturing sites
- Designing new QC training programs and lab event workflows
- Providing CQV oversight for the construction of a new state-of-the-art manufacturing facility.
Our Markets
Our teams of Owner’s Representatives and SME Consultants work in partnership with our clients to enable the compliant, efficient supply of niche-regulated products to patients across three distinct areas of global life sciences manufacturing.
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.
Biologics / Cell & Gene Therapy
Supporting our partners to develop and manufacture complex biologics represents a third of our global business and i-Pharm is proud to assist clients in spearheading the development of tomorrow’s treatments.
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.
What we do
"i-Pharm GxP ensures patient access to life-saving therapeutics through human-centric partnerships, projects, and solutions."
i-Pharm GxP is a specialist consulting partner focused on the practical execution of defined projects, not high-level strategy or advisory work. We are engaged to deliver outcomes on the ground.
We provide the technical expertise and delivery capacity our clients need to resolve business-critical manufacturing challenges without disrupting day-to-day operations.
Our work is designed to:
- Improve the speed, reliability, and efficiency of manufacturing operations through process, systems, equipment, automation, and digital enablement
- Maintain compliance with evolving global regulatory expectations, supporting inspections and ongoing regulatory readiness
i-Pharm GxP is engaged to create lasting impact. We combine project delivery with knowledge transfer and capability building, ensuring your teams retain the skills and confidence to sustain improvements long after the project is complete.
Custom Solutions
We strategically assess each engagement to design a custom solution that aligns scope, resourcing, cost, and delivery risk into a Scope of Work (SOW), ensuring value for money and desired outcomes.
Intelligent Networks
We offer the balance of a precise and agile workforce, staffed to defined SOWs, ensuring the right expertise is deployed at the right stage of each project.
Embedded Relationships
We commit to solving our clients’ challenges in-house and on-site, working as Owner’s Representatives and SMEs to deliver projects, transfer knowledge, and embed sustainable ways of working that outlast our physical presence.
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
- Supper 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
Scoping Your Project
Every successful engagement starts with a clear understanding of your manufacturing environment, objectives, and constraints. We take the time to understand what you are trying to achieve, where the risks sit, and what success looks like.
We believe that people make projects. By understanding your objectives, challenges, and existing team structures, we can shape the right delivery approach and deploy the right expertise to achieve the desired outcomes.
Our scoping process looks beyond technical requirements to include operational realities, site culture, and practical constraints, ensuring the solution we design will work in the real world.
Every scope is protected by NDAs, enabling open and transparent conversations and a clearly defined Scope of Work.
Scope a project with i-Pharm GxP
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Highest Quality Personnel
All consultants are selected specifically to deliver the agreed Scope of Work. Through a rigorous vetting process, including technical testing, 360 reference checks, and face-to-face meetings, we deploy experienced Owner’s Representatives and SMEs who are accountable for outcomes, not just activity. We do not operate a bench model.
Matching Timelines
We move at the pace your project demands and can deploy consultants within two weeks of a detailed brief. Our agile model allows the workforce to scale up or down in line with the critical path of each project.
Governance
Effective management and delivery of milestones and objectives underpin the success of every project. Our clients determine the level of governance required for each scope, regardless of team size, supported by clear project plans and regular stakeholder reviews.
Retention
We maintain a 96% retention rate for consultants on assignment because we believe that people make projects. Selecting and retaining the right people ensures continuity, knowledge retention, and reliable delivery throughout each engagement.
Knowledge Transfer
All of our work product is owned by our clients. Where possible, we prioritise knowledge transfer, training, and capability building of your FTE workforce to ensure improvements endure long after project completion.
Transparent Pricing
We operate with fairness, transparency, and balance in the pricing of every engagement. Our business philosophy is built on repeat, referral, and relationship-based partnerships, earned only by delivering long-term value for our clients.
Say hello to your GxP team
Listen to the i-Pharm GxPodcast
The GxPodcast by i-Pharm GxP is a podcast that shares conversations of thought leadership and perspectives on GxP solutions in the life sciences industry. Click below to listen in!
