Our complete CMC services during registration/application include, among many others:
- CTD Mod. 2 and 3 writing, review and/or updates for the EU and US
- Dossier gap analysis
- Due-diligence of in-licensing dossiers
- Expert support on responses to deficiency letters
- Expert reports.
Check out our #serviceminipill to see how ASPHALION can help you with CMC solutions during Registration or Application!
For further information, please contact us at: [email protected]