Regulatory Affairs Services.
Focused solutions.
Designed to support a pan-EU/US development strategy.
Services from early preclinical development to marketing authorization and product lifecycle management.
- QA/QMS development
- Global PV strategies
- Regulatory roadmaps & strategies
- RA/PV/QA due-diligence
- Target Product Profiles
- SME designation
- Early FDA/EMA/UK engagements
- Orphan & paediatric strategies
Arriello experts in Europe and the US work within a project team to provide coherent regulatory strategies and operational support.
We offer tailored and optimized services, leveraging the
right solution, either in the US, Europe or combined.
Bluefish Pharmaceuticals, Sweden
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
Berit Lindholm.
CEO, Bluefish Pharmaceuticals, Sweden