We offer technical expertise and timely and sustainable solutions to help our clients address concerns with compliance, operating costs and capital investments, asset location and manufacturing efficiency, and facility and equipment readiness to meet future business and production requirements. We can provide strategic advice on upgrading and redeveloping existing facilities to acquiring sites in new geographical regions, conducting full life cycle cost analysis as well as insightful analysis on rapidly-changing technologies that are driving drug development and lean manufacturing operations.
Our robust business process enables us to assist clients to shortlist, analyze and appraise options, assessing both non-financial benefits and risks.
- Pre-feasibility and Feasibility studies
- Funding and Investment appraisal
- Assets integrity management
- Capital Program management
- Business and strategic planning
- Concept design / master planning
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- Basic and detailed engineering
- Engineering, procurement, and construction management (EPCM)
- Project and construction management
- Building Information Modelling (BIM)
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Review and Selection of Equipment and Technology for Bulk and Secondary Manufacturing Plants, R&D, Warehouse and Infrastructure Support Facilities
With scientific change and the evolution of new diseases and medical treatments, pharmaceutical and biotechnology clients frequently require facilities with well-designed, contained material follow, volume/capacity and production flexibility, transferrable analytical technologies, good manufacturing practices, all the while meeting stringent health and safety regulations.
We have extensive expertise in the design, engineering and construction management of bio/pharmaceutical manufacturing plants, research and development centres, clean rooms, specialized laboratories and controlled environments (including the highest containment levels and biological safety levels), as well as the design and specification of equipment, integration of new process equipment and modifications to existing systems, without disrupting ongoing production activities.
- Formulation and dosage facilities (solid, liquid, vial and inhalers)
- Sterile suites and packaging
- Research and development facilities
- Laboratories
- High-containment laboratories and facilities
- Clean rooms
- Aseptic suites
- Flexible facilities
- Production and packaging facilities
- Medical devices
- Containment and process safety
- Laboratory and clean room design
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- Specialty testing
- Quality assurance
- Scanning facilities
- Architectural and engineering design
- Process intensification
- Process modelling
- Automation
- Software development
- Refrigeration
- cGMP
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Commissioning, Qualification and Validation Services to Ensure Compliance
We work with clients at start-up to ensure facilities are compliant with GMP and regulatory agency requirements, and through our qualification and validation services use advanced risk-based approaches and tools to authenticate and ensure that everything - processes, utilities, manufacturing equipment, ventilation systems and temperatures, humidity, airflows, water quality and supply chain, among others - performs smoothly and meets client specifications.
- Integrated commissioning and qualification (ICQ)
- Validation master plan (VMP)
- Validation protocol format
- Design qualification (DQ)
- Installation qualification (IQ)
- Operational qualification (OQ)
- Performance qualification (PQ)
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