Aleon Pharma
International
Contact Us
Regulatory Affairs
European Medicines Agency (EMA) Services
Aleon stands ready to support your drug development and approval in the EU.
Meetings with EMA and Local Authorities
- Scientific Advice Meetings
- Meetings with CHMP
- Pre-MAA Meetings
Regulatory and Medical Writing
- Investigational Medicinal Product Dossier (IMPD)
- Investigator’s Brochure (IB)
- Clinical Protocol
- Informed Consent Form
- Pediatric investigation plans (PIP)
- MAA
ODDs and Expedited Programs
- Orphan Drug Designations
- PRIME
- Accelerated Assessment
- Exceptional Circumstances
- Conditional Marketing Authorization
