The team members of the Coordination Unit of the Andalusian Network for the design and translation of Advanced Therapies are experts in the different phases involved in the development of an advanced therapy medicinal product.
Our area of expertise ranges from the preparation of the preclinical evidence to justify the start of a clinical trial through the adaptation of the manufacturing process to comply with GMP regulation, the clinical trial design and monitoring, to the finding of strategic associates. We have proven experience providing consultancy services in the development and manufacture of advanced therapy medicinal products.
Basic and Preclinical Development
- Analysis of research lines
- Support for the design of the experimentation
- Seek scientific advice from the pertinent Regulatory Agencies
- Preparation and updating of documentation
Clinical Trials
- Design and planning of clinical trials
- Clinical trial start- ups
- Support throughout the development of clinical trials
- Surveillance of the medicinal product safety
- Data processing of clinical trials
Clinical Scale Manufacturing and Development
- Centralisation of many quality control services
- Product development and manufacturing
Consultancy
- Strategic and regulatory compliance
- Strategic product development and partnership
Training
- Actividades de formación especializadas en Terapias Avanzadas
