UK Regulatory Affairs Services

Maintain your business effective and compliant in the post-Brexit UK market

UK Regulatory Affairs Services

After the UK’s withdrawal from the European Union took place, the UK regulatory context separated from that of the European Union, what posed a challenge for pharmaceutical companies in order to understand to what extent their market activity would be affected.

This change led to the need of providing support both for adapting past casuistries to the new regulatory environment and to generate strategic projects for new commercialization, such as in:

Clinical and pre-approval support
Registration and authorisation
Post-approval and product maintenance support

Altogether, these services are provided based on the following aspects:

Assessment of the regulatory impact and development of a Brexit transition strategy for your company
Management of MAH transfers and other necessary variations
Continuous update on the regulatory requirements dictated by the MHRA due to Brexit

UK Regulatory Affairs Services Solutions

Pre-approval Support (application and entity requirements)

National Scientific Advice with MHRA
Product designation: Orphan drug designation (ODD) application, ATMPs, Cell and Gene therapies
Paediatric Investigational Plans within the UK framework
Clinical Trial application
Investigator’s Brochure (IB)
Generation of clinical evidence to support future registration
Support in selection of most convenient indication and target population

Registration and authorization

Elaboration of CTD and other UK-contextualized required technical documents
Gap analysis of your current documents and update of CMC, non-clinical and clinical counterparts for UK submission
Writing for registration of all types of products within all therapeutic areas: Strong expertise with innovative NCE, ATMPs, Biologicals and Biosimilars
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 products.
Management of eSubmissions accepted by MHRA
- Comprehensive eCTD services
- eCTD compilation and publishing
- Full life-cycle support for Europe, USA, Canada, Switzerland, Saudi Arabia, GCC, and more
- Information Management (RIMS solution)
- Software installation, training, validation, support

Post-commercialization

Product maintenance, including update of regulatory dossiers, variations and amendments:
- Efficiency for variations, renewals, and notifications.
- Complete portfolio maintenance
- Management of labelling
- Promotional material review for UK
Local support for pharmacovigilance:
- Acting as your UK-QPPV:
  - Audit PV System and support for set-up of Quality System
  - Preparation of PSMF, RMP, PSURs, and handling of Case Management
- Reporting adverse events and submissions of PSURs to MHRA
- Batch update of all your records with the new QPPV and PSMF information in the Article 57 database
- Holding your pharmacovigilance system master file at our location

Strategic and operational local support

Acting as your UK-based MAH
Acting as your UK-local contact with MHRA
Re-establishing your SME status
Responsible Person for Import (RP-I)

UK specific Medical Device regulatory support

Assistance with local competent authorities’ communication
Product registration
Other local requirements
Manufacturer and supplier audits
QMS self-inspections
Notified body mock inspections

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Discuss your case with our experts and receive a valuable feedback

Why Asphalion?

Asphalion is fully prepared and experienced in acting as a local UK support to successfully manage your relationship with government and medical entities (MAH, MHRA, among others). As such, our experts are aware of the post-Brexit new regulatory requirements.

In fact, Asphalion counts with an office in the United Kingdom to help manage potential key contacts with regulatory entities to facilitate any administrative issue related to clinical development, registration, commercialization and adequate product maintenance.

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