Specialized Services
Our business model is based on 4 major categories of services: strategic advisory & technical consulting, engineering design, project management, technical support
Strategic advisory and technical consulting services throughout the entire lifecycle of pharmaceutical/biotechnology facilities and processes. From initial feasibility to the final audit through rigorous analyses, a forward-looking perspective and expert guidance.
A comprehensive technical and economic assessment of a pharmaceutical or biotechnology project, considering regulatory, technological, logistical and market aspects. This makes it possible to make informed decisions on the feasibility and scalability of the project.
Medium and long-term strategic design of the development of a production site, aligned with capacity needs, GMP regulations, functional flows and business growth. As a result, a clear roadmap is created for progressive investments.
Development of a detailed cost-benefit analysis that justifies a pharmaceutical or technological investment, assessing expected returns, risks, timeframes and alternatives. This facilitates management decision making and the prioritisation of resources.
Definition of the most suitable technological production strategy based on the type of product, selecting the required production platform, the critical technologies and type of machinery. This establishes a solid basis for a design aligned with the objectives of efficiency, scalability and regulatory compliance.
Design of production processes with emphasis on efficiency, quality and safety, including containment solutions adapted to the required degree of toxicity or sterility. This assures robust processes and regulatory compliance from the outset.
Advising on the transfer and scaling up of biotechnology processes from development to commercial production, optimising critical parameters, technological platforms and validation strategies. This reduces scale-up times and technical risks.
Analysis and technical specification of the most suitable equipment for each stage of the process, aligned with functional, integration and regulatory needs. This guarantees investments that are technologically sound and aligned with the client’s objectives.
Assessment of the toxicological profiles of APIs or intermediates to define acceptable exposure limits and containment and cleaning strategies. This permits effective risk management and compliance with GMP.
A structured assessment of the degree of plant digitalisation and automation, identifying gaps, opportunities and the roadmap for digital transformation.
A diagnosis of the environmental, social and governance (ESG) performance of the plant, with proposals for carbon footprint reduction, energy efficiency and waste management. This fosters a pharmaceutical operation aligned with sustainable goals.
A critical review of facilities, processes and documentation from a GMP, technical and operational standpoint. This detects deviations and areas for improvement, and proposes corrective actions to assure the compliance status as well as regulatory and operational readiness.
Complete technical solutions for GMP and regulated environments, from conceptualisation to final execution.
Defines the best technical and strategic solution for each project, assessing feasible design alternatives based on regulatory, functional and economic criteria. This makes it possible to establish a solid basis for the submission of the project to the different regulatory Agencies for validation and to advance confidently in the following phases.
Designs robust and efficient production processes, complying with GMP standards and considering flows, mass and energy balances and P&ID. This guarantees the integrated design of product, technology and operating environment.
Establishes the commissioning, qualification and validation (CQV) strategy from the initial stages to assure traceability, regulatory compliance and efficiency in the validation. This reduces reworks and assures GMP-aligned commissioning.
Management of the technical and administrative processes required to obtain the necessary licences and permits, complying with town-planning and industry-specific requisites. This assures legal compliance and avoids delays in project execution.
Development of complete technical documentation of the project (diagrams, reports, calculations and specifications) ready for the tender process and execution. Provides precise technical definition and multidisciplinary consistency.
Models all the elements of the project (architecture, facilities, processes) in a 3-dimensional BIM environment, integrating disciplines and detecting interferences. This improves co-ordination and reduces construction risks.
Preparation of technical documents and evaluation criteria for the tender process, and provides support in comparing bids. Facilitates the selection of technically solvent and competitive contractors.
Co-ordinates the development of the project during the engineering and tender phases, ensuring compliance with the scope, technical consistency between disciplines and overall planning. Oversees deliverables, manages interfaces and prepares the smooth transition towards the construction execution phase.
Critically reviews the design of facilities, processes and systems in relation to GMP, operational and user requirements, identifying deviations, gaps or risks. Provides a structured technical report with recommendations to ensure conformity to standards, robustness of the design and readiness for audits, qualification or execution.
Integrates digital solutions (BMS, MES, SCADA, eBMR…) starting from project design, facilitating automation and traceability. Prepares the plant for the challenges of the Pharma 4.0. industry.
Incorporates sustainability criteria in engineering design, prioritising energy efficiency, material selection and reduction of the environmental impact. Contributes to compliance with ESG goals and environmental regulations.
Drafting of URS documents that define the technical, functional and regulatory needs of systems and equipment. Serves as the basis for specification, design, procurement and validation.
Development of detailed technical specifications for the acquisition of equipment and facilities. Ensures that the purchased solutions comply with design, quality and GMP requirements.
Service adapted to each stage of the project: initiation, definition and/or execution. Integrated approach to the management of engineering, tender process, construction, commissioning, qualification and co-ordination of activities, ensuring compliance in terms of costs, timeframes and qualities, and contributing additional value from start to finish.
Co-ordination of onsite execution of the project through Project Managers, Site Managers and engineers, integrating BIM tools for technical and construction control. Guarantees alignment of design with construction and timing.
Management of the necessary processes to obtain licences and permits from the local authorities and competent bodies. Ensures the legality of the project and prevents administrative blocks or delay.
Conducts technical audits and monitoring of the installers responsible for adapting the engineering design to the construction designs. Verifies that consistency with the base design, GMP standards and defined quality criteria is maintained.
Control of the project budget through ongoing analysis of costs and deviations, and financial planning. Optimises the use of resources and ensures compliance with the defined economic goals.
Organisation and control of all the documentation generated during construction (plans, certificates, reports, non-conformities, etc.), ensuring traceability, integrity and regulatory compliance. Facilitates audits and document closure.
Undertakes co-ordination in relation to health and safety during execution, applying preventive measures and controlling occupational risks. Protects the physical integrity of persons and guarantees legal compliance during construction.
Exercises professional management of the project, supervising the execution technically in line with the regulations and the approved project. Acts as technical liaison between management and the building developer, ensuring compliance with the scope.
Oversight and co-ordination of all the systems and facilities commissioning and qualification phases, from review and approval of the DQs to execution of Commissioning, IQ and OQ. Verification that the design has been implemented correctly, that the systems work according to operational requirements and GMP, and that traceability and documentations standards are met. Ensures effective transition towards the operating phase and final validation.
Ensures that facilities, systems and personnel are ready to start operations in accordance with GMP. Includes training, change management and start-up protocols.
Openness to new technological challenges and willingness to accompany growth strategies. We offer continuous technical support, training, consultancy and accompaniment in innovation initiatives within the biotechnology and pharmaceutical sector.
Analyses existing production and operational processes to identify bottlenecks, inefficiencies or deviations. Proposes and implements improvements to increase performance, traceability and compliance.
Offers the integration of specialist technical profiles (engineers, project managers, CQV or BIM specialists) at the client’s facilities. Contributes flexibility, knowledge transfer and operational continuity.
Designs and accompanies industrial scale-up processes from pilot or laboratory settings, considering the technical, regulatory and capacity impact. Reduces risks and ensures efficient transfer to production settings.
Drives innovation in the plant by identifying and integrating new technologies, digital solutions and disruptive improvements. Favours competitiveness, sustainability and continuous evolution of the production environment.
Develops sustainability plans focused on efficient maintenance, environmental certification (such as LEED or BREEAM) and regular monitoring of performance. Guarantees operational continuity and ESG alignment.
Management and update of the project BIM model as a digital asset integrating facilities, spaces and processes. Facilitates maintenance, lifecycle management and future modifications.
Implements digital twins that virtually replicate the facilities and processes, integrating data in real time. Permits simulations, predictive analysis and decision making based on real operational behaviour.
Regular technical and functional audits are carried to verify the state of the facilities, regulatory compliance and operational efficiency. Makes it possible to detect deviations, anticipate risks and plan improvements.
Development and provision of technical and operational training adapted to engineering, production or quality teams. Reinforces internal skills development and guarantees the efficient and compliant use of facilities and systems.
Draws up Standard Operating Procedures (SOP) adapted to technical, operational and maintenance processes. Ensures consistency, regulatory compliance and standardisation of critical operations.