Asphalion Offers Regulatory Solutions in the United Kingdom and Support with New MHRA Requirements for Brexit Transition
We are your local UK support to successfully manage your relationship with government and medical entities (MAH, MHRA, and others). As such, our experts are fully aware of the new regulatory requirements post-Brexit.
Some of the Local Support We Can Help You with in the UK Medical and Pharmaceutical Regulatory 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)
Local Support for 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 Support (Application and Entity Requirements):
– National Scientific Advice with MHRA
– UK Orphan Drug Designation Application
– UK PIP
– Clinical Trial Application
Registration and Post-Approval (Facilitation of Medical and Pharmaceutical Regulatory Affairs):
– 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
Brexit: Changes in MHRA Regulatory Requirements and Strategy
At Asphalion we are up to date with all the changes in regulatory requirements for Brexit, therefore, we can be your partner and advise you successfully in your UK strategy:
– Asses your regulatory impact and develop your Brexit transition strategy
– Manage MAH transfers and other necessary variations
– Keep you informed of the regulatory requirements dictated by the MHRA due to Brexit.
How to contact our office in the UK?
Choose Asphalion as your local partner in the UK.
If you need more information about medical and pharmaceutical regulations or have questions about how to approach your strategy for Brexit changes, please contact us and our experts will be in touch to answer your questions.
Do you need support or more information about the services? Contact us!