Regulatory Affairs
Regulatory clarity for health and medical technology
We support medical device, IVD and digital health companies with practical regulatory expertise, helping you navigate requirements, prepare documentation and achieve efficient market entry.
50+
Years combined experience
100+
Life science projects delivered
20+
Global markets
01 – REGULATORY LANDSCAPE
Navigating complex regulatory requirements
Key regulatory challenges we help you address
Regulatory requirements across UK, EU, US and global markets continue to evolve. We help you understand what’s required, identify gaps and move forward with clarity.
Evolving regulatory frameworks
Changing requirements across MDR, IVDR, FDA and UKCA create complexity and uncertainty.
Clinical evidence expectations
Demonstrating safety and performance requires structured, well-supported clinical evidence.
Technical documentation gaps
Incomplete or inconsistent documentation can delay approvals and increase review risk.
Submission and approval strategy
Engaging with regulators and notified bodies requires clear strategy and well-prepared documentation.
KEY STATISTICS
The complexity of regulatory pathways
Regulatory requirements continue to evolve across global markets. These figures highlight the challenges companies face in achieving and maintaining approval.
67%
of 510(k) submissions trigger an additional information request
13–18 months
Average MDR certification review time at Notified Bodies
11,000+
Devices removed from the EU market under MDR since 2022
02 - OUR CAPABILITIES
Regulatory support from development through to approval
Key regulatory challenges we help you address
From first NHS engagement to multi-market commercial launch, we provide end-to-end support tailored to your product and commercial objectives.
Technical documentation and submission readiness
We develop and review technical documentation aligned with global regulatory requirements, supporting efficient submissions and successful approvals.We guide clients through NHS procurement, NICE evaluation and Supply Chain approval.
Technical documentation
Technical file compilation across the full product lifecycle
Design, manufacturing, testing and labelling documentation
Risk management and usability engineering files
Clinical and submission support
Clinical evaluation and performance data
Literature reviews and state of the art analysis
Submission preparation and regulator interaction support
Gap analysis and remediation
Identify missing elements, assess regulatory gaps and define a clear, prioritised path to compliance.
Regulatory strategy and planning
Define regulatory pathways aligned with product type, classification and target markets.
Risk management and usability
Development of risk management and usability files aligned with global requirements.
Submission support
Preparation and support for submissions, including interaction with notified bodies and regulators.
Clinical evaluation and evidence
Structured evaluation of clinical data to support safety, performance and regulatory requirements.
Post-market regulatory support
Ongoing support to maintain compliance, including updates, surveillance and lifecycle management.
03 - OUR APPROACH
How we support your regulatory journey
Clear, structured support at every stage
We work alongside your team to plan, prepare and deliver regulatory activities efficiently and effectively.
1: Regulatory assessment
Review product type, classification and target markets to define requirements, priorities and potential regulatory risks.
2: Strategy and planning
Define the regulatory pathway, documentation needs and submission approach aligned with your product and commercial objectives.
3: Documentation development
Prepare technical files, risk documentation and clinical evidence in line with applicable regulatory requirements and standards.
4: Submission and review support
Support submissions and interaction with notified bodies and regulators throughout the review and approval process.
5. Post-market support
Support ongoing compliance, updates and lifecycle management to maintain regulatory approval and market access.
04 - WHO WE SUPPORT
Supporting companies across the product lifecycle
Who we work with
We support organisations across health and medical technology, from early-stage development through to approval and post-market compliance.
Medical device and IVD companies
Regulatory support across development, documentation, submission and compliance.
Established manufacturers
Support to maintain compliance, manage change and expand into new markets.
Digital health and AI companies
Support for software and AI-enabled products navigating evolving regulatory requirements.
Investors and portfolio companies
Regulatory input to support product development, readiness and growth.
Startups and scale-ups
Practical support to establish regulatory foundations and prepare for market entry.
Innovation and research organisations
Support translating early-stage innovation into compliant, market-ready products.
Speak to the team
Get clear, practical support across your regulatory journey, from development through to approval and beyond.