Securing approval from the Medicines and Healthcare products Regulatory Agency (MHRA) is a critical step for any company looking to develop, manufacture, distribute, or market medicinal products in the United Kingdom. Whether you're a global pharmaceutical firm launching a new site, a biotech startup scaling R&D, or a medical device company entering the UK post-Brexit, the regulatory bar is high—and the process is rigorous.
Engaging an experienced MHRA application consultant is the most effective way to streamline your approval process, avoid delays, and ensure long-term compliance. At Fraser Bond, we support this journey by helping firms secure MHRA-compliant facilities, prepare documentation, and connect with leading regulatory advisors.
MHRA consultants provide expert guidance on:
Preparing and submitting MHRA applications for:
Manufacturer’s Licence (MIA/MHRA)
Wholesale Distribution Authorisation (WDA(H))
Marketing Authorisations (MA)
Clinical Trial Authorisations (CTA)
Facility readiness assessments, including GMP or GDP compliance
Regulatory strategy tailored to your product type (e.g., ATMPs, biologics, devices)
Pre-inspection support and audit preparation
Post-approval compliance monitoring and variation submissions
For new market entrants, consultants also help align operations with post-Brexit regulatory changes and international harmonisation efforts.
You need MHRA consultancy if:
You're launching or acquiring a UK manufacturing or distribution site
You're conducting UK-based clinical trials
You're seeking a UK Marketing Authorisation for a medicinal product
You're transitioning from EU to UK-specific licences post-Brexit
You're expanding operations and need site variation or licence amendments
The MHRA conducts site inspections before granting most licences. That means your physical premises must meet regulatory requirements in terms of:
Hygiene and segregation
Environmental controls
Security and access
Standard operating procedures (SOPs) and documentation
Temperature-controlled storage and product traceability
Failure to demonstrate these standards can delay or prevent approval.
Fraser Bond works closely with MHRA application consultants to help clients meet all property-related requirements for regulatory success. Our services include:
We locate facilities with the structural potential and infrastructure needed to pass MHRA inspection—across manufacturing, warehousing, and R&D environments.
We assist in preparing layout plans, lease agreements, and usage summaries required during the MHRA application.
Whether in life sciences corridors like Oxford-Cambridge, or logistics hubs near Heathrow, we align property search with your supply chain, staffing, and compliance needs.
We connect clients with top-tier MHRA consultants specialising in biologics, ATMPs, sterile manufacturing, and post-market surveillance.
A North American pharmaceutical firm entering the UK engaged Fraser Bond to secure a GDP-compliant distribution hub. Within 8 weeks, we:
Sourced and negotiated a long-term lease in a logistics zone pre-approved for health use
Provided regulatory consultants to prepare MHRA WDA(H) submission
Aligned lease terms with inspection timelines and SOP finalisation
The client received approval and operational greenlight within their 90-day UK entry window.
MHRA authorisation is a non-negotiable requirement for pharmaceutical operations in the UK. With timelines tightening and compliance standards increasing, expert MHRA application consultants play a vital role in ensuring smooth and successful approval.
Fraser Bond complements this expertise by delivering the regulatory-ready premises, documentation, and support infrastructure needed to meet MHRA expectations. For international companies and UK-based firms alike, we are the property partner that enables compliance and accelerates market access.
