Strategy for Pharma & Biomed
Specialized expertise for a continuously evolving sector
In the pharmaceutical and biomedical industry, we support our clients with multidisciplinary teams providing engineering, validation, regulatory affairs, and process digitalization expertise. From research and development to production, we deliver flexible and reliable solutions fully aligned with international regulations.
As the industry navigates the challenges of decarbonization, digital transformation, and regulatory evolution, we empower our clients with the technical expertise and flexibility they need to lead in this new era.
Versatile competences for the Evolving Pharma & Biomed Sector
We design and optimize facilities and infrastructures for pharmaceutical and biomedical production, ensuring quality, efficiency, and regulatory compliance.
- Feasibility studies and facility master planning
- Design of clean rooms and controlled contamination environments
- HVAC systems design and process utilities
- Design of solid, liquid, and sterile production plants
- Regulatory compliance (GMP, FDA, EMA).
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We provide expertise in the validation of processes, systems, and GMP environments, supporting clients in compliance with FDA and EMA standards.
- Process validation and cleaning validation
- Equipment qualification (IQ/OQ/PQ)
- Software and computer system validation (CSV)
- Definition and implementation of quality plans
- Internal audits and support during regulatory inspections.
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Our professionals assist clients in managing regulatory aspects and compliance activities, from registrations to technical documentation.
- Preparation of registration dossiers and submissions
- Drafting of technical documentation and reports
- Alignment with ICH, FDA, EMA guidelines
- Monitoring of regulatory updates
- Support during compliance audits.
We collaborate on the development of new processes and products, focusing on research, scale-up, optimization, and technology transfer.
- Lab scale development and proof of concept
- Scale-up of production processes
- Tech transfer from R&D to manufacturing
- Process parameter optimization
- Introduction of new technologies and automation.
We support clients in managing complex projects across the entire value chain, from initial concept to commissioning, with integrated approaches and agile methodologies.
- Feasibility studies and project scope definition
- Planning and scheduling (MS Project, Primavera, Agile)
- Budgeting and cost control
- Risk management and mitigation plans
- Coordination of multidisciplinary teams
- Support during commissioning and handover.
We turn Engineering & IT challenges into tailored solution for your business.
By your side from Design to Delivery
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