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Find out how we can support you with advanced solutions for the pharmaceutical industry.
We design new plants and optimize existing ones with GMP-ready approach: feasibility studies, separate layouts and flows, PFD/P&ID and technical specifications, mechanical-electrical-instrumental coordination. We intervene on processes, packaging, utilities and cleanroom. We prepare and conduct FATs and SATs with plans and checklists to verify requirements and safety before/after installation, accelerating commissioning, reducing changes and stabilizing performance.
Validation and Qualification (IQ/OQ/PQ)
We manage end-to-end validation: VMP and URS, IQ/OQ/PQ protocols, test execution and reporting for audit readiness (AIFA/EMA/FDA). We align facilities and systems to GMP and EU GMP Annex 1 (including CCS), maintaining traceability and data integrity. The outcome is systems fit for purpose, documented and auditable throughout the lifecycle, with minimized risk of noncompliance.
We design automation with PLC/HMI, SCADA supervision and MES for control, batch genealogy and EBR. We apply CSV and 21 CFR Part 11 to ensure Data Integrity, integrate IT/OT and, when useful, robotics and vision. Real-time visibility enables rapid decisions, reduces errors and variability, supports predictive maintenance and full batch traceability, improving performance and compliance.
We use FEM, CFD and DEM to validate the design before commissioning. CFD for cleanroom airflow, chemical processes, medical device air-drop and filtration; DEM for granular dynamics: gentle transport of tablets/capsules, mixing and coating. FEM for strength, vibration and pressure testing. Simulations reduce risk, optimize sizing and make performance predictable.
We produce comprehensive documentation for use, maintenance and compliance: manuals, SOPs, technical files, maintenance plans and spare parts lists, integrating training for operators and maintainers. The document package standardizes processes, expedites inspections and onboarding, improves safety and ensures business continuity. The document structure is aligned with GMP requirements and facilitates audits and updates over time.
We make 3D video animations to explain pharmaceutical machines and processes: exploded views and sections that illustrate assembly, maintenance, and cleanroom procedures. At trade shows and online they overcome logistical constraints, clarify benefits in seconds, and generate qualified conversations. We can integrate interactive totems, configurators, and 3D OOH content. Storyboards and messages are consistent with GMP, Annex 1, and Data Integrity.
Leverage our know-how to optimize your pharmaceutical devices.
We Listen to Your Needs
Every project begins with a detailed analysis of the client’s needs, identifying technical objectives, regulatory requirements, and industry specifics.
We Create Tailored Solutions
Our multidisciplinary team combines expertise in biomedical engineering, automation, and simulation to provide you with customized solutions that fully meet required standards.
We Deliver Certified Results
Developed solutions are tested and validated using advanced simulations and rigorous protocols, ensuring certified results, operational safety, and full regulatory compliance.
Do You Have a Project in Mind? Let’s Talk!
We are here to help you transform complexity into reliable solutions, working alongside you in every engineering challenge.