Since being established in 1999 we have successfully delivered over 500 projects to our customers within the EU, US and Asia and have summarised the highlights of these in the list below. We are proud to have been able to help our customers achieve their quality and compliance goals. Our commitment to working with our clients to provide tangible results is demonstrated through a high rate of repeat or retained service.
Business process re-engineering to improve efficiency and compliance of existing medical device distribution systems.
Computer Systems Compliance consulting for enterprise systems and in-house developed systems and programmes.
GMP compliance audit and QP consulting services.
Business process improvement project. Strategic eClinical consulting.
GMP compliance programme. GMP compliance audit and action plan. GMP strategy. Validation and compliance project management.
Validation project management of ERP business system.
Biologics manufacturing validation project management. Computer Systems Compliance consulting. GMP training.
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
QMS program for the European manufacturing sites.
Business critical remediation project for clinical supply chain operations. Strategic consulting and tactical project management support to improve quality and GCP compliance.
Computer Systems Compliance support for ERP system. GDP compliance consulting for facility expansion project.
GXP compliance program for the SaaS products being rolled out to global pharmaceutical and life science organisations.
Computer Systems Compliance audit and action plan. Computer Systems validation project management for implementation of global ERP system.
Computer Systems Validation Training. Periodic Validation Review. Calibration and Maintenance Management Engineering Systems. GXP Compliance Audit.
Outsourced Computer Systems compliance and QA service provider for GMP and GCP operations. Supplier audit management.
Validation consulting support for EDMS.
GCP Training and consulting.
Computer Systems Compliance for SAP applications. GXP compliance audit and remediation plan, training and implementation of QMS.
Computer systems compliance strategy for use of cloud based applications for delivering GLP and GCP tools and services to customers based in the EU, US and Asia.
Computer systems compliance assessment for materials management systems (GDP operations).
Delivery of GXP compliance improvement programme. Provision of interim QA Manager support during site relocation project.
Computer Systems Compliance audit and action plan for multiple sites. Computer Systems validation project management for implementation of global business systems.
Technology transfer. Business process improvement project. Strategic eClinical consulting. Validation project management for new facilities and upgrades to key production operations.
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
Outsourced Computer Systems compliance and QA service provider for GMP and GCP operations. Supplier audit management.
Computer Systems Compliance consulting and training for GCP operations.
Business process improvement study for quality systems
Management and delivery of compliance improvement program for GMP operations (QS analytical laboratories)
QP consulting services for registration and release of IMP. Supplier audit (biologics) and preparation of submission dossier.
GMP compliance audit and remediation plan. MHRA licence approval. QP consulting services.
Project Management for major process automation upgrade as an integrated part of the overall capital investment plan to drive improvements to manufacturing capacity.
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
Guy’s and St Thomas’ NHS Foundation Trust and King’s College Hospital NHS Foundation Trust – GMP Compliance Audit and provision of QP consulting services for GMP operations.
Technology transfer. Business process improvement project. Business-critical compliance remediation projects. Strategic consulting and tactical project management support to improve quality and compliance.
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods. GMP improvement and process efficiency improvement project delivery (biologics manufacturing).
Computer Systems Compliance training, audit and action plan. Risk assessment and implementation of QMS. Validation project management for the implementation of Enterprise business systems.
GCP Training and consulting.
Delivery of GMP training programme for UK facilities.
Development of intranet-based project management, engineering and GMP compliance systems and tools. Validation project management. Generation of KPI metrics for performance measurement of Project Engineering operation.
IT compliance strategy and computer systems validation project management. System rationalisation and data migration project management (GxP compliance).
QA compliance improvement programme for regulatory operations of the European operation. Independent assessment of regulatory improvement project on behalf of the MHRA and IMB.
Computer Systems compliance and IT QA consulting services
Delivery of GCP training programme.
QP consulting services for release of licensed veterinary products. Risk assessment and implementation of QMS.
Business-critical compliance remediation projects. Strategic consulting and tactical project management support to improve quality and compliance. QP and QA consulting services. Delivery of GMP training programme for product manufacturing facility.
QMS gap assessment and process improvement (GMP operations)
Validation project management (GMP manufacturing operations)
Computer Systems Compliance consulting and training for GXP operations.
GXP compliance program for the suite of hosted services (IaaS, PaaS) being delivered to customers around the globe.
QP consulting services for release of licensed veterinary products. Risk assessment and implementation of QMS.
GxP compliance and validation consulting for the mHealth business unit.
QP consulting services for the registration and release of licensed homeopathic products. Computer Systems Compliance audit and action plan. Computer Systems validation project management for implementation of global ERP system.
(Now part of Pfizer) Strategic project management and validation management for the implementation of a green field biotechnology manufacturing facility.