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