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End-to-end solutions in regulated environments
Full support from preclinical and development phases to industrial production, validation, and commercialisation.
Advanced Therapies and Health Sciences
The Centre of Excellence in Advanced Therapies and Health Sciences acts as a strategic partner for companies in the pharmaceutical, biotechnology and contamination-controlled sectors, providing advanced services throughout the entire development cycle of regulated products. From industrial production environments to clinical trials, we deliver technical and regulatory solutions through a distributed structure that combines close customer engagement with the support of highly qualified multidisciplinary teams. Our integrated approach allows us to support cutting-edge projects by delivering efficiency in critical solutions. We bring extensive experience in pioneering technology projects with a significant societal impact.
We connect science, technology and engineering to create value in the life sciences
We drive innovation in biotechnology and life sciences through specialised solutions covering the entire lifecycle of regulated products. We work closely with pharmaceutical, biotech and related organisations, adapting to their technical and regulatory needs through an agile, client-focused structure. Our goal is to be a strategic partner, combining expert knowledge, distributed capabilities and a forward-thinking vision to progress together on high-impact projects. We strive for excellence to make a difference where science becomes health.
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Specialised technical and regulatory expertise
GxP consulting, validations, quality assurance, and regulatory compliance aligned with EMA, FDA, and other agencies.
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Focus on innovative therapies and medical products
Experience in ATMPs, biologics, medical devices, combination products, and emerging technologies.
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Operational support for industrial environments
Process engineering, plant optimisation, equipment and facility validation, CSV, and quality assurance.
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Agile project management and distributed capabilities
Expert multidisciplinary teams working in a coordinated manner at both local and international levels.
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Multi-sector adaptability
Applying our expertise to diverse sectors, including human and veterinary pharmaceuticals, biotechnology, cosmetics, functional foods, and digital health.
Related solutions
01Technical, regulatory, and industrial support throughout the lifecycle of healthcare products
Companies developing pharmaceutical, biotechnological, or healthcare products must comply with stringent technical and regulatory standards. Our solution offers expert support throughout the entire product life cycle — from early development to industrial validation and market entry. We provide technical, regulatory, and industrial assistance tailored to EMA, FDA, and GxP requirements, with a practical, rigorous, and results-driven approach. Our multidisciplinary team combines engineering, quality assurance, and regulatory expertise to ensure each project advances with safety, efficiency, and full compliance.
Related services
- Regulatory consultancy (EMA / FDA / GxP)
- Validation of processes, equipment and facilities (CSV, IQ/OQ/PQ)
- Process engineering and plant optimisation
- Quality assurance and GMP compliance
- Document Management
02Clinical Supply and Specialised Support in Clinical Operations
Clinical trials—particularly those involving advanced therapies, biotechnological products, and innovative medicines—demand a highly specialised approach. Our solution delivers clinical, technical, and logistical support from preclinical stages through to Phase III, offering an integrated service that ensures regulatory compliance, operational efficiency, and full traceability at every stage of the trial. We support sponsors and CROs with services including end-to-end clinical supply, digitalisation of operations, and documentation management within GCP-compliant environments, adapting to the complexity of each study and the most stringent regulatory frameworks.
Related services
- Clinical Supply Operations (end-to-end)
- Support for ATMP and biotech clinical studies
- GCP documentation and traceability management
- Digitalisation of clinical operations
- Technical and regulatory support across all phases
Technical, regulatory, and industrial support throughout the lifecycle of healthcare products
01Technical, regulatory, and industrial support throughout the lifecycle of healthcare products
Companies developing pharmaceutical, biotechnological, or healthcare products must comply with stringent technical and regulatory standards. Our solution offers expert support throughout the entire product life cycle — from early development to industrial validation and market entry. We provide technical, regulatory, and industrial assistance tailored to EMA, FDA, and GxP requirements, with a practical, rigorous, and results-driven approach. Our multidisciplinary team combines engineering, quality assurance, and regulatory expertise to ensure each project advances with safety, efficiency, and full compliance.
Related services
- Regulatory consultancy (EMA / FDA / GxP)
- Validation of processes, equipment and facilities (CSV, IQ/OQ/PQ)
- Process engineering and plant optimisation
- Quality assurance and GMP compliance
- Document Management
Clinical Supply and Specialised Support in Clinical Operations
02Clinical Supply and Specialised Support in Clinical Operations
Clinical trials—particularly those involving advanced therapies, biotechnological products, and innovative medicines—demand a highly specialised approach. Our solution delivers clinical, technical, and logistical support from preclinical stages through to Phase III, offering an integrated service that ensures regulatory compliance, operational efficiency, and full traceability at every stage of the trial. We support sponsors and CROs with services including end-to-end clinical supply, digitalisation of operations, and documentation management within GCP-compliant environments, adapting to the complexity of each study and the most stringent regulatory frameworks.
Related services
- Clinical Supply Operations (end-to-end)
- Support for ATMP and biotech clinical studies
- GCP documentation and traceability management
- Digitalisation of clinical operations
- Technical and regulatory support across all phases
Contact
Our team of specialists in engineering, technology, digital transformation, and R&D&I supports you at every stage, delivering comprehensive solutions tailored to your needs. Regardless of the scale of the challenge, at RDT we are committed to finding the best solution.
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