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.