GxP Consulting
Medical Devices / Combination Products
Tailored Support
We offer specialist, tailored support to Class I, II, and III Medical Devices and Combination Products, ensuring their safe and reliable delivery to patients.
i-Pharm GxP brings a global lens to navigating complex regulatory requirements that impact Medical Device & Combination Product manufacturing. Our consultants support compliance with FDA QSR (21 CFR Part 820), MDR, and cGMP requirements in the U.S., as well as EU MDR 2017/745 and EU IVDR 2017/746 in Europe. This ensures our partners’ products remain aligned with regulatory standards across geographies.
Beyond initial launch, we support post-market adjustments such as product updates or modifications to maintain ongoing regulatory compliance. This commitment to quality, safety, and adaptability underpins the lasting partnerships we’ve built with our partners in the Medical Device space.
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 Partner
As a trusted partner in the Medical Device space, we operate with a patient-first mindset and a commitment to driving meaningful cultural change.
Our focus extends beyond project delivery and validated SOPs or engineering upgrades, with a strong emphasis on knowledge transfer and embedding day-to-day practices that safeguard patient safety over the long term.
Comprehensive Solutions
i-Pharm GxP partners closely with clients to understand their specific challenges, allowing us to deliver tailored solutions that strengthen patient safety and device performance. By prioritising collaboration and communication, we help our partners navigate the complexity of medical devices and combination products with confidence.
As your specialist Medical Device and Combination Products partner, i-Pharm GxP supports the delivery of compliant manufacturing operations aligned with global regulatory expectations.
