Your European partner for integrated
Regulatory Pathways & Clinical Supply

Specialized in Advanced Therapies
Supporting Clinical Supply across all IMPs
About us
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1

Scientific Expertise

Cell Therapies • Gene Therapies • Tissue Engineering • Innovative Medicines

Scientific Expertise

Cell Therapies • Gene Therapies • Tissue Engineering • Innovative Medicines

2

Regulatory Expertise

EMA • AEMPS • CTA • IMPD • Scientific Advice • Hospital Exemption

Regulatory Expertise

EMA • AEMPS • CTA • IMPD • Scientific Advice • Hospital Exemption

3

Quality Expertise

GMP • QMS • Audits •Trainings • CAPA • Vendor Qualification

Quality Expertise

GMP • QMS • Audits •Trainings • CAPA • Vendor Qualification

4

Operational Expertise

Global Clinical Supply • QP Release • Import/Export • Biorepository services

Operational Expertise

Global Clinical Supply • QP Release • Import/Export • Biorepository services

We combine the strategic vision of a regulatory consultancy with the operational capabilities of a GMP clinical development partner

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Our services

From quality foundations to clinical execution
One Partner, Two Specialized Divisions

Regulatory Pathways

Regulatory suggests in-depth and expert management of regulations, approvals from agencies and technical and legal knowledge.

Regulatory Pathways
Precise Supply

Supply emphasizes our capabilities to ensure that necessary resources and products are consistently and reliably made accessible where and when they are needed.

Precise Supply
Regulatory Pathways

"My deepest gratitud to Advanthera and Regulatory Pathways team for their unwavering support. What began as an immunological idea is now the first targeted secretome in Phase I-II human trials, approved by the EMA and the first of its kind. This achievement would not have been possible without your guidance and expertise."

CEO – Biotech developing Advanced Therapies

Regulatory Pathways

"Gradocell is not just a consultancy firm; it's your indispensable partner in the conception, development, and implementation of Advanced Therapy Medicinal Products Production Units. We seamlessly integrate into your team, providing unwavering support every step of the way."

Partner at a Hospital In Madrid – Advanced Therapies Unit

Precise Supply

"We manage the entire supply chain with meticulous care, ensuring the success of your clinical trial from planning to closure. With our comprehensive end-to-end approach, we provide unwavering support for your clinical trials."

Santiago de Vega
General Manager, Advanthera Precise Supply

Precise Supply
Insights

Our case studies, blog and press

Discover all
General
Insights
2025.02.20
From research to patients: Building a solid strategy in advanced therapy development
Bringing an advanced therapy from research to patients requires far more than scientific innovation. Early planning, regulatory strategy, preclinical development and product characterisation all play a critical role in building a successful development pathway.
General
Insights
2025.02.19
European collaboration and the future of Advanced Therapies
European collaboration plays a key role in Advanced Therapy development, bringing together research centres, hospitals, companies and regulatory experts to help transform innovation into future clinical applications.
General
Podcast
2025.02.18
Implementing Regulation (EU) 2024/1689
Laying down harmonised rules on artificial intelligence (AI) Guidance to Medical Device Manufacturers
General
Insights
2025.02.17
Celyvir: A two-decade journey in advanced cancer therapy
From preclinical research to clinical studies, the story of Celyvir highlights the scientific, regulatory and operational challenges involved in advancing innovative therapies towards patient application.