Entities and organisations:
– Act as your UK-based MAH
– Act as your UK-local contact with MHRA
– Re-establish your SME status
– Responsible Person for Import (RP-I)

Pharmacovigilance:
– Act as your UK-QPPV
– Reporting adverse events and submissions of PSURs to MHRA
– Batch update all your records with the new QPPV and PSMF information in the Article 57 database
– Hold your pharmacovigilance system master file at our location

Pre-approval:
– National Scientific Advice with MHRA
– UK Orphan Drug Designation Application
– UK PIP
– Clinical Trial Application

Registration and post-approval:
– Submission in UK using the new National Portal
– National procedures in UK; accelerated and rolling reviews, national variations
– Amended packaging and leaflet
– Baselines for grandfathered centralized products

We can also:
– Asses your regulatory impact and develop your Brexit transition strategy
– Manage MAH transfers and other necessary variations

How to contact our office in the UK?

Mail: london@asphalion.com
Address: Wells House 80, Upper Street, London, N1 ONU, United Kingdom
More information