Consulting Center

ICMED S.r.l. is the leading company in Italy and Europe for consulting services aimed at JACIE-FACT accreditation of haematopoietic stem cell transplant programmes. We support centres from start-up through to inspection, including documentation system design and staff training.

FACT (Foundation for the Accreditation of Cellular Therapy) is the US accreditation body, while JACIE (Joint Accreditation Committee ISCT-Europe & EBMT) is the European counterpart. Both use the same international FACT-JACIE standards. ICMED supports centres for both accreditations.

ICMED S.r.l. offers specialised consulting to Assisted Reproductive Technology (ART) centres for regulatory compliance, quality management and inspection preparation. Our team has direct experience with CNT/CNS requirements and European directives on tissues and cells.

Yes, ICMED S.r.l. supports clinical laboratories on the path to ISO 15189 accreditation, which certifies technical competence and quality management systems. We offer consulting for quality system design, staff training and audit preparation.

ICMED uses a structured phased methodology: initial assessment of the current state, gap analysis against the reference standard, action plan development, quality system implementation with staff training, internal audits, and support during the final inspection. Each project is customised to the specific needs of the centre.

ICMED consultants have over 20 years of direct experience in the transplant and cell therapy sector. In addition, we offer proprietary technology tools (IAAPP and IAAPP) that no other consultant provides. We operate across 3 continents and have supported over 100 facilities, bringing international best practices to every project.

Timelines vary depending on the centre's starting point. For a programme already operational that needs to structure its quality system, the process typically takes 12 to 18 months. For a complete start-up, timelines can reach 24 months. ICMED works to optimise timelines without compromising the quality of preparation.

ICMED offers a hybrid model: activities requiring physical presence (internal audits, on-site training, mock inspections) are carried out at the centre, while document support, quality system review, and indicator monitoring can be managed remotely through our digital platforms. This approach reduces costs and speeds up timelines.

ICMED supports centres throughout the entire CAR-T qualification process: from unit design and organisational workflow, to staff training according to GMP and FACT-JACIE requirements, to preparation for GMP facility inspections. Our team has direct experience with the qualification processes of all major commercial CAR-T manufacturers.

Yes, maintaining accreditation requires ongoing commitment. ICMED offers continuous support services including: periodic internal audits, document system updates to the latest standards, Management Review support, quality indicator monitoring, and preparation for surveillance visits. Many of our clients maintain an annual support contract.

Yes, ICMED operates across 3 continents: Europe, Africa, and the Middle East. We have supported facilities in Spain, Portugal, Greece, Turkey, UAE, Saudi Arabia, Egypt and other countries. Our international experience allows us to understand each country's regulatory specificities and adapt our consulting approach to the local context.

Yes, ICMED S.r.l. has adopted an integrated Management System certified ISO 9001:2015 (quality), ISO/IEC 27001:2024 (information security), and UNI/PdR 125:2022 (gender equality). This guarantees our clients that we operate according to the same standards of excellence we require of the facilities we support.

Each project is quoted on a bespoke basis after a free initial assessment that defines the scope of work. The investment depends on the scope (JACIE accreditation, CAR-T, PMA, ISO 15189, etc.), the centre's starting point, and the estimated duration. We offer flexible payment plans and the possibility to modulate support intensity based on available budget.