GxP Consulting
Sterile / Aseptic Manufacturing
Trusted Partner
With a 12-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.
We have a deep understanding of the cutting-edge new technologies that offer accelerated sterile-injectable production gains, proven expertise implementing the latest intelligent systems that provide real-time analysis and data to better inform decision-making; and a firm grasp on the nuances of the modern regulatory landscape for sterile/aseptic therapeutics.
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 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
- 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 (Trackiwse, 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
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
- Functional Service Provider (FSP)
- Clinical Trial Oversight & Management
- Clinical Operations
- Biostatistics
- Data Management
Patient-first Approach
i-Pharm GxP works with a patient-first approach and an understanding that, as an external consultancy, we must have a commitment to delivering holistic cultural change and ensuring knowledge transfer and lessons learnt beyond our project teams and the revamped SOPs and engineering upgrades that we validate.
Working with people to foster understanding and develop the day-to-day behaviours and practices that outlast our physical presence and ensure patient safety is a key motivator behind our every engagement.
Flexible Networks
From Clean Rooms to Flexible Fill-Finish lines and from Laboratories to Clean and Black Utilities we partner with clients to enable the compliant, efficient manufacture of regulated sterile/aseptic products such as Vaccines, liquid/semi-solids, APIs, and Parenteral products to patients around the world.
Whether you have capacity or capability challenges, our services can be relied upon to provide you with a flexible network of industry experts.
