At BCI we have the breadth and depth of technical expertise to respond to the complex challenges of major engineering projects. We have the skills, knowledge and proven experience to plan, design, manufacture and implement the solutions to complete the project. We offer an integrated solution to pharmaceutical and medical devices sector. Whether the goal is to efficiently introduce a new processing suite or packaging line to a manufacturing facility or design new production lines, BCI brings its broad expertise to any project by developing creative solutions from concept to implementation and startup. BCI has assembled an expert team with experience in a wide range of industries and production environments. We are recognized for our innovation, resourcefulness, and responsiveness, as we serve the pharmaceutical, biotech, medical devices and healthcare sector. BCI provides onsite engineering services and project management for employee augmentation, to full scale projects including new facilities and complete turnkey project solutions. You can be confident we will deliver equipment and facility design solutions that can be efficiently and effectively executed to meet current and future commercial operation goals. Providing a broad range of engineering services, BCI is proud of our ability to work in collaboration with all stake holders, including supply chain, materials procurement, plant operations, vendors, marketing, corporate quality, packaging and R&D. Our clients can be reassured by the fact that our consultants, engineers, and project managers have previously worked in the industry and have first-hand experience with the challenges you face. We understand your business drivers and will bring inspired new ideas to your projects. Our teams work with pharmaceutical clients worldwide during the strategic planning stage, providing site master planning, concept studies, feasibility studies, and front-end design. When you have secured capital funding, we can put together a multidisciplinary team to deliver a full Engineering, Procurement, Construction Management, and Validation offering. Our international presence enables us to build you the best project team using our consultants and engineers. Our industry leaders and our experts can integrate with your team to ensure complete collaboration with your supply chain. Our pharmaceutical support does not end when a capital project is completed: we have teams of engineers who work constantly on site, providing both operational and business improvement services. Not only do we deliver this support using partnerships to ensure that you get the highest level of flexibility and value, we also provide the ongoing benefits of our expertise applied at site level. Programme Management At BCI, we focus on the context of the project and perform strategic tasks and deal with business strategies and objectives. Our highly qualified consultants work closely with you to prioritise and select projects that most fit your business needs and our business case approach always considers the full asset lifecycle. Our programme management experts provide strong and expert guidance from the start of a project to its planning, design and process development, procurement, manufacturing process, and execution stages. By taking a full programme view, our consultants understand where improvement opportunities are and we then construct project plans to realise these opportunities.
BCI are experts in project management and concentrate on providing a full spectrum of project management services. We deliver projects effectively and on time by finding the right expertise at the right stage of the project and by appropriate preparation of business cases right from the inception of the project from Concept through Feasibility, Detail Design, Planning, Execution, Commissioning, Validation and Benefit Realisation against business objectives and priorities. Our services are fully customisable to suit your exact needs.
At BCI, we are dedicated to providing comprehensive assistance throughout the entire tech-transfer process. With our extensive expertise, we have successfully conducted tech-transfers. Our primary focus is on the rapid scaling-up, tech-transfer, and validation of processes while prioritizing product quality.
Whether it involves assessing the available equipment at a new site, identifying critical process parameters, or transferring manufacturing and quality control methods, we are here to assist you in ensuring a seamless and streamlined transfer process.
Our design, construction and commissioning engineers work collaboratively with our project teams from the project inception stage to ensure that better quality GMP facility gets built by adhering to all relevant current regulations and quality standards.
Engineering Project Management
AT BCI our engineering project management consultants with their technical knowledge and management skills guarantee that all aspects of a project or system from inception and feasibility, engineering, procurement and implementation through to commissioning and operation are considered and integrated into a whole. We ensure that emphasis is placed on financial, planning and management aspects of the project life cycle, at every stage of a project providing an integrative force for essential teamwork in industry.
We aim to place the best possible price to meet a purchaser’s demand in terms of quantity, quality, dimensions and site. We provide procurement documents as an integral part of the early stages of project initiation. Our team focuses on preparation of a Procurement Plan which will be compliant with current regulatory requirements. The design of the plan ensures health and safety requirements without affecting the quality. We take into consideration required user specifications and supplier provided functional specifications to conduct commissioning, qualification documentations and validation. We ensure method statements and risk assessments are in place prior to commencement on site. We ensure suppliers meet obligations in terms of delivery, installation, commissioning, documentation, qualification and validation.
FAT and SAT Protocols and Reports
BCI helps to perform FAT (Factory Acceptance Test)-Testing of equipment and relevant documentation at the vendor ‘s site against the requirements of an approved test protocol and SAT (Site Acceptance Test) – Testing of equipment and relevant documentation at the site of use of the equipment against the requirements of an approved test protocol. We assist in preparing protocols and test reports for the smooth execution of the FAT and SAT trials as per the “GMP” requirements.
Manufacturing Process Development
Significant problems can occur during full scale production when manufacturing processes are poorly conceived. That’s where BCI comes in! BCI helps in designing a robust manufacturing process that will consistently meet your needs by implementing various management tools such as new development processes, quality tools like six sigma and design for manufacturability (DFM). This means whatever skills you have – or don’t have – in your team, we’re there to fill in the gaps. We help to develop a good new product development process by analysing, monitoring and controlling various activities of the organisation right from project initiation to business phase, development, validation and implementation and finally manufacturing / commercialisation.
“CHANGE” as the word implies is a need of every organisation that will generate sustainable and tangible benefits so that the business excels. For change to be successful, people need to adapt to new ways of working. We at BCI work with you to articulate a clear vision and objective for change. Clients engage BCI because they wish to embed change within their organisation that will bring them measurable benefits. For change to be successful we assist people in your organisation and gain their confidence to make them understand the outcomes from the change by involving and communicating efficiently to them the need of change, its implementation and the realisation of profit thereby reducing disruption to the business.
BCI helps to manage your organisation’s risk strategically by offering a holistic approach while operating within current regulations and guidelines that protect and drive sustainable growth. We can help you understand the likelihood and impact of diverse risks on your operations, systems, people and processes. BCI’s approach is to work together with our clients and along with our expertise and client capabilities we can design and deliver risk management solutions which provides a complete risk methodology uniquely tailored for your business requirements in a cost-effective manner. Our risk management methodology consists of a number of phases right from risk evaluation to planning, modelling risk assessments and analyses, implementing measures, follow-up, control and reporting.
Start-up and commissioning
Our consultants can confirm that the installation of components and the operation of equipment’s meet the specified design and Good Engineering Practice (GEP) and that all equipment’s, utilities and systems in the organisation are safe to operate and fully functioning.
Consultants at BCI, with their experience and expertise in a broad range of continuous improvement techniques enable our clients to operate more efficiently. We help our clients to achieve the performance optimization that they need to achieve vital competitive advantage and achieve strategic results by incorporating Six Sigma and Lean technologies. As Continuous Improvement is an incremental process we can support you to identify appropriate methods by process benchmarking, creating plans to identify inefficiencies and then redesign and optimise the process and implement the change.