Services
GxP Consulting
i-Pharm GxP
Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific.
With over 12 years of experience meeting business-critical GxP needs for our partners, our network of technical experts will work with you to scope your requirements, identify key risks and opportunities, and agree on milestones for successful delivery.
We believe that every challenge is unique, which is why we adopt a tailor-made solution for each engagement; creating a roadmap for delivery that is purpose-built to your specific needs.
i-Pharm GxP meets all requirements in-house, eliminating complex supply chains and increasing value.
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 three distinct areas within global life sciences.
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 Consulting 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 offers the exclusive commitment of an expert partner that will give you the control and confidence to meet your specific challenges head-on. We combine tactical, turnkey consulting teams with precision search & selection services in order to:
- deliver immediate impact
- enable successful & standalone growth for our partners.
i-Pharm GxP is engaged to impact lasting change and we commit to providing your organisation with the skills, knowledge and personnel necessary to resolve your issues beyond the end of our specific engagement.
Intelligent Networks
We proactively attract, develop & retain the best talent in the industry & motivate them to succeed.
Innovative Solutions
We strategically assess each engagement to build a custom solution and deliver value for money.
Inclusive Relationships
We commit to solving our partner's problems in-house and work hard to impact lasting change.
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.
Project Solutions
If your business is experiencing significant change which requires a timebound, coordinated, and milestone-led solution, involving niche resources potentially in numerous locations, you can rely on us to deliver the right response.
Previous examples have included upgrading equipment and technology, transferring production to an additional or new site, responding to time-critical external audits, decommissioning an existing facility, or launching a new product or service.
Matching Timelines
We will move as quickly as your timelines allow, and all our networks are guaranteed to be available within 2-3 weeks of an introduction, pending drug screens and background checks.
Highest Quality Personnel
Our rigorous vetting process allows us to present only the best-suited professionals that have received top reviews from prior projects or have come highly recommended by others.
Retention
We have a 96% retention rate for consultants on assignment.
Governance
For all projects, we meet bi-weekly with the Project Team and Hiring Team to discuss and track the progress. We also provide a quarterly presentation on the overall status of the project.
Transparent Pricing
All our consultants are deployable within the ranges quoted in our rate card (excluding travel expenses)
