Typical services we provide:

• Scoped projects
• Seconded services
• Tailored involvement according to client or project requirements
• Independent or fully integrated

Typical activities we perform:

Process Engineering

• Process design & development and HAZOP and HAZAN
• Process optimisation and up-scaling including materials and personnel flows
• Commissioning (at the manufacturer's and client's site)
• Supplier and equipment suitability assessment and evaluation
• Detailed engineering reviews including risk assessments

Qualification and Validation

• Development and execution of lean qualification and validation documentation
• Qualification of process & laboratory equipment, utilities and facilities
• Validation of processes, analytical, cleaning and sterilisation methods
• GAP analysis and focused remediation of existing qualification / validation packages

Project Management

• Project & resource management for both small individual and large scale projects including client's own resources and/or third party contractors and suppliers.
• Planning management to allow rapid return to service of equipment and minimise downtime
• Interface with the various project shareholders e.g. end users, technical support services, engineering and quality units

Consultancy

• Development or enhancement of Quality systems and underlying methodologies
• Development or enhancement of procedures to deliver lean and efficient interpretation of regulatory requirements based on the client's specific activities
• Technical and/or regulatory compliance related consultancy
• cGMP, Quality and Facility audits for clients and third party suppliers
• Risk Assessments (for process robustness, cGMP compliance etc.)
• Quality Assurance support including Clinical Trails, Laboratory, R&D and Production
• Regulatory inspection support and follow-up
• Training (GMP, GEP, technical skill and process specific)