Consulting > Regulatory Compliance and Project Management
Service Overview
GxP Consulting has many years of experience in advising on how to best meet the regulatory requirements of the MHRA, FDA, EMEA, HTA, WHO and ICH. Our consultants are highly skilled and experienced in identifying, communicating, managing and delivering your Good Manufacturing Practice (GMP), Good Automated Manufacturing Practice (GAMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GPvP) and Good Distribution Practice (GDP) requirements. By understanding your product, your process and your markets, we can advise on what you need to comply with and how to achieve this.
Validation
Whether it is a single stand-alone equipment item or an entire facility, the GxP team is able to support you with the planning, management and implementation of validation. With a huge amount of accumulated knowledge and experience, our team of validation project managers, validation engineers and validation scientists is able to help your business complete its validation requirements.
Quality Assurance Support
Our experience includes the setting up, documentation design, management and assessment of Quality Assurance operations in many organisations. GxP Consulting is able to support with the QA management and responsibilities throughout your business including clinical studies, computer systems, manufacturing, packaging, warehouse and laboratory areas.
Project Management
Project Management is a discipline that requires appropriate skills, training and experience. GxP recognises this and is able to provide your business with the support you need to deliver your projects efficiently and effectively. We are able to provide you with a project management service that integrates and understands the requirements of the entire drug development lifecycle from pre-clinical through to the manufacture and distribution of approved drug products.
We are able to provide you with a resource that has knowledge and experience that combines the discipline of project management with a comprehensive technical understanding of the development, approval, manufacture, packaging, storage and distribution of pharmaceutical, biopharmaceutical, medical device, veterinary and homeopathic products. These services are available to you as part-time, full-time, interim and project-specific support services to suit your business needs.
Strategic Consulting
- Development and implementation of the Quality Management System (QMS)
- Corporate and Site Validation Strategy
- Analytical assay development and validation
- Preparation of the Validation Master Plan (VMP)
- Process Validation (PV) strategy and preparation of the Process Validation Master Plan
- Cleaning Validation (CV) strategy and preparation of the Process Validation Master Plan
Tactical Services
- Interim and part-time Validation Manager support facilities (on-site and remote services)
- Clinical Study Project Management
- Validation Project Management
- GMP Risk Assessment
- GMP Impact Assessment
- Interim and part-time QA Management support (on-site and remote services)
- Equipment validation (e.g. autoclaves, lyophilisers, spray dryers, packaging lines, filling machines, LAF units, reactors, vessels, filters, dryers, coaters, ovens, laboratory equipment and much more)
- Utilities validation (e.g. HVAC, Clean Steam, CIP, SIP, Air, Nitrogen, Pure Water / WFI)
- Validation protocol preparation and implementation
