Empowering innovation in Advanced Therapies through scientific and regulatory expertise
⚖️Regulatory Support
ATMP classification and dossier preparation
EMA/FDA interactions and compliance
GMP and clinical trial authorization guidance
🔬Scientific Consulting
Project design and preclinical strategy
Technology transfer and process validation
Quality and documentation support
🎓Education & Training
Workshops on ATMP regulation and development
Customized training for research teams / educational programs
Scientific writing and communication
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Jimena Álvarez Freile, PhD