Expert consultancy in ATMPs
Focus on CMC, technical, regulatory and strategic development
Our services
Process development and optimization
Regulatory consulting
Preparation for submissions and audits
Technical and scientific mentoring
Customized training programs
Clients
Biotechnology Startups and SMEs
Academic groups with translational projects
Clinical researchers developing innovative therapies
Clinical centers looking to deliver new treatments
Expertise
I am a highly experienced leader in the field of Advanced Therapy Medicinal Products (ATMPs), with over a decade of expertise spanning scientific research, regulatory compliance, and operational management. I have held senior roles in renowned organizations, where I led multidisciplinary teams, oversaw cell and tissue banking operations, coordinated several ATMPs development projects and ensured adherence to ISO 9001, AABB, GMP, and GDP standards.
My background combines hands-on laboratory management with strategic business development, focusing on continuous process improvement, risk-based thinking, and stakeholder engagement. I have successfully managed budgets, optimized resources, and implemented quality control programs for cryopreserved products and ATMPs. My regulatory knowledge is complemented by direct experience with Infarmed and the EMA, including scientific advice procedures.
My commitment
Technical rigor and alignment with current regulations
Focus on the effective transition from science to application
Customizable and flexible approach
Contact us
Send us a message.
