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.
Our expertise encompasses both ISO 13485 and ISO 14971 standards, and we have a successful track record with EU MDR/IVDR implementation projects and 21 CFR Part 820 delivery.
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 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
- Environmental Monitoring
- Clean Rooms design and engineering for laboratory and manufacturing facilities
- Microbiology/Immunology
- Assay Development and Testing
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
- 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
- BLA – Biological License Applications
- Working experience supporting Regulatory Bodies including FDA, MHRA, EMA, COFEPRIS, PMDA
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
- 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 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
- 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 Partner
As a trusted partner in the medical device field, we recognise the importance of a patient-first approach and a commitment to fostering holistic cultural change.
Our focus extends beyond our project teams and the SOPs and engineering upgrades we validate, as we also prioritise knowledge transfer and the development of long-lasting, day-to-day practices that ensure patient safety.
Comprehensive Solutions
At i-Pharm GxP, we work closely with our clients to cultivate an understanding of their unique needs and challenges, enabling us to deliver comprehensive solutions that have a lasting impact on patient safety and overall device performance. By emphasising collaboration and communication, we are able to help our partners navigate the complex landscape of medical devices and combination products with confidence.
Choose i-Pharm GxP as your specialist Medical Device and Combination Products partner and let us guide you through the intricate process of developing, manufacturing, and ensuring regulatory compliance for your innovative solutions.
