Pharmaceutical regulatory support for the UK market
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines and healthcare products in the United Kingdom. Companies entering the UK market must follow applicable marketing authorisation, manufacturing, quality and post-authorisation requirements.
Regulatory support for new and existing UK authorisations
RIAR Consulting provides regulatory support to pharmaceutical companies seeking to introduce new products, maintain existing authorisations or manage regulatory changes within the UK market.
Following Brexit, the UK has its own regulatory framework under the MHRA. For medical devices, we guide clients through UKCA marking, registration and compliance requirements while maintaining alignment with international regulations.
Our MHRA regulatory services
Support from market entry and marketing authorisation through GMP compliance and lifecycle management.
- 01
UK regulatory strategy and market entry
- Assessment of UK regulatory requirements
- Identification of suitable marketing authorisation pathways
- Regulatory gap assessment and documentation planning
- Evaluating applicable national and international recognition routes
- 02
Marketing authorisation support
- Preparation and review of marketing authorisation documentation
- Support for new marketing authorisation applications
- CTD/eCTD dossier preparation and technical review
- Documentation for generic and other applicable products
- Product information, labelling and packaging documentation
- 03
GMP and manufacturing compliance
- GMP documentation review and gap assessment
- Manufacturing site and quality documentation
- Review of manufacturing and quality control records
- Inspection-readiness support
- 04
Variations, renewals and lifecycle management
- Marketing authorisation variations
- Assessment of changes to processes, specifications and product information
- Renewal application documentation
- Regulatory impact assessment for post-approval changes
- 05
Regulatory correspondence and deficiency responses
- Review of MHRA queries and requests for information
- Preparation of technical responses
- Resolving documentation gaps
- Regulatory communication and submission coordination
- 06
Medical devices (UKCA)
- UKCA marking support
- Registration requirements
- Ongoing compliance with UK requirements
A structured approach to the UK market
Each engagement follows the same structured sequence, adapted to the product and the applicable UK route:
- Understanding the product, its development or marketing status and your regulatory objectives
- Assessing the applicable regulatory pathway, authority and documentation expectations
- Identifying gaps in technical, quality and administrative documentation
- Preparing, reviewing and compiling documentation to the market’s requirements
- Supporting submission readiness, authority correspondence and query management
- Lifecycle support for variations, renewals, regulatory changes and documentation maintenance
Our objective is to help companies approach UK regulatory requirements with appropriate documentation, a clear submission strategy and ongoing regulatory oversight.
How VERA 2.0 supports this sector
UK authorisations depend on GMP-compliant manufacturing and inspection readiness. VERA 2.0 adds continuous visibility into the plant conditions behind them.
- VERA 2.0
GMP manufacturing visibility
Continuous visibility into facility, environmental and equipment conditions relevant to GMP, where supported by connected systems.
- VERA 2.0
Earlier identification of abnormal conditions
Anomaly identification flags unusual patterns so authorised personnel can investigate in good time.
- VERA 2.0
Inspection-readiness records
Structured event records and advisories support internal reviews and the preparation of inspection documentation.
- VERA 2.0
Change and variation context
Operational context on equipment and process conditions supports assessment of manufacturing changes that may require a variation.
VERA 2.0 is an advisory decision-support system. It does not write to or control plant systems, and it does not replace the site’s quality management system, validated records or regulatory determinations. Capabilities depend on the systems connected at each site.
Planning to enter or expand in the UK?
Whether you are preparing a new marketing authorisation, managing variations or addressing MHRA queries, RIAR Consulting can support your regulatory objectives.