Asphalion supports research consortia as SME Regulatory Expert Partner:
- Experience in proposal preparation and application process
- First successful grant agreement in 2013 (iHIVARNA)
- Participation in a total of 5 research consortia
- Overall potential funds of over 24 million euros
Asphalion can support with the following activities:
- Orphan Drug Designation application
- Paediatric Investigation Plan
- Regulatory Roadmaps
- IMPD / IB for Clinical Trials
- Clinical Trial Applications
- Scientific Advice / Protocol Assistance
- Clinical / Nonclinical/CMC development plans
- SME application to EMA
Expertise in a wide variety of product types
- Biosimilar
- Biotech
- Cell Therapy products
- Gene therapy products
- Herbal products
- Medical Devices
- Plasma derived products
- Small molecule
If you are interested please contact us: [email protected]