Clients
Since being established in 1999 we have successfully delivered over 300 projects to our customers within the EU and US 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.
Abbott
Business process re-engineering to improve efficiency and compliance of existing medical device distribution systems.
Allergan
Computer Systems Compliance consulting for enterprise systems and in-house developed systems and programmes.
Allergy Therapeutics
GMP compliance audit and QP consulting services.
Almac
Business process improvement project. Strategic eClinical consulting.
AMRI
GMP compliance programme. GMP compliance audit and action plan. GMP strategy. Validation and compliance project management.
Aspar
Validation project management of ERP business system.
Avecia
Biologics manufacturing validation project management. Computer Systems Compliance consulting. GMP training.
Baxter
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
Boehringer Ingelheim
Computer Systems Compliance audit and action plan. Computer Systems validation project management for implementation of global ERP system.
Biogen Idec
Business critical remediation project for clinical supply chain operations. Strategic consulting and tactical project management support to improve quality and GCP compliance.
Oxford BioMedica
GCP Training and consulting.
Chugai
Validation consulting support for EDMS.
Colpitts
GCP Training and consulting.
Crossgate
Computer Systems Compliance for SAP applications. GXP compliance audit and remediation plan, training and implementation of QMS.
ESG
Delivery of GXP compliance improvement programme. Provision of interim QA Manager support during site relocation project.
FDAS
Implementation of x-docs™ 'Hosted' QMS module.
GlaxoSmithKline Pharma - Manufacturing
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
GlaxoSmithKline - Pharma R&D
Computer Systems Compliance audit and action plan for multiple sites. Computer Systems validation project management for implementation of global business systems.
GlaxoSmithKline - Biologicals
Technology transfer. Business process improvement project. Strategic eClinical consulting. Validation project management for new facilities and upgrades to key production operations.
HFL Sport Science
Implementation of x-docs™ QMS module.
HMR
Computer Systems Compliance consulting and training for GCP operations.
Imperial College London
QP consulting services for registration and release of IMP. Supplier audit (biologics) and preparation of submission dossier.
Kimal Plc
GMP compliance audit and remediation plan. MHRA licence approval. QP consulting services.
Lonza
Project management for business-critical validation projects and refurbishment projects during short, fixed shut-down periods.
The Medicines Company
Implementation of x-docs™ QMS module. Implementation of x-train™ module. Development of forms based processes including CAPA and Change Control tailored to customer operations.
NHS
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.
Novartis - Vaccines and Diagnostics
Technology transfer. Business process improvement project. Business-critical compliance remediation projects. Strategic consulting and tactical project management support to improve quality and compliance.
Novartis-Sandoz
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.
Novozymes
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).
Nutricia
Computer Systems Compliance training, audit and action plan. Risk assessment and implementation of QMS. Validation project management for the implementation of Enterprise business systems.
Oxagen
Computer Systems Compliance consulting and training for GCP and GLP operations. Implementation of x-docs™ QMS module.
Perrigo
Delivery of GMP training programme for UK facilities.
Pfizer
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.
Phlex Global
Development of SharePoint integration solutions. Technical Project Management for delivery of a portfolio of business critical projects.
Quotient
Computer Systems Compliance consulting and training for GCP operations. Implementation of x-docs™ QMS module. Technical Project Management support for delivery of overall programme.
Ranbaxy Laboratories Ltd
QA compliance improvement programme for regulatory operations of the European operation. Independent assessment of regulatory improvement project on behalf of the MHRA and IMB.
Renovo
Computer Systems Compliance consulting and training for GCP operations. Implementation of 'Hosted' CAPA Forms Based Process module.
Respiratory Clinical Trials
Delivery of GCP training programme.
Robinsons Healthcare
QP consulting services for release of licensed veterinary products. Risk assessment and implementation of QMS.
Thermo Fisher Scientific
Validation project management (GMP manufacturing operations)
Vectura Group Plc
Computer Systems Compliance consulting and training for GXP operations.
Virbac
QP consulting services for release of licensed veterinary products. Risk assessment and implementation of QMS.
Vodafone
GxP compliance and validation consulting for the mHealth business unit.
Weleda
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.
Wyeth
(Now part of Pfizer) Strategic project management and validation management for the implementation of a green field biotechnology manufacturing facility.
