International Compliance & Multi-Regional Support
Take your products and operations across borders with confidence. We help you align quality systems and regulatory strategies across the United States, Canada, the United Kingdom and the European Union.
Expanding into new markets multiplies regulatory complexity. Each authority has its own requirements, procedures and expectations, and a quality system built for one market may not satisfy another. Since Brexit, companies supplying both the UK and the EU must also manage separate MHRA and EU requirements.
Radical Pharma Consultancy has team members based in Canada, the United States and the United Kingdom, with careers spanning North American and European pharmaceutical companies. We use ICH guidelines as a common foundation and then address the specific requirements of each region.
The result is a coordinated approach: one set of well-aligned systems and dossiers rather than separate, duplicated efforts for every market.
International Compliance Services
ICH Guidelines Implementation
Build globally aligned systems on the internationally harmonised standards that major regulators share.
- Pharmaceutical quality system (ICH Q10)
- Quality risk management (ICH Q9(R1))
- Good clinical practice (ICH E6)
- Lifecycle management (ICH Q12) and CTD format (ICH M4)
Multi-Regional Submissions
Plan and coordinate submissions across markets to save time and avoid inconsistencies.
- Sequencing strategy for US, Canada, UK and EU filings
- Core dossier with regional modules
- Alignment of labelling and product information
- Coordination of regional agency questions
Cross-Border Audit Support
Audits of sites, suppliers and partners wherever they are located.
- Supplier, CMO and CRO audits internationally
- Remote and on-site audit options
- Audit programmes for global supply chains
- Harmonised audit reporting and follow-up
Global Regulatory Intelligence
Stay ahead of changing requirements in the markets that matter to you.
- Monitoring of new and revised guidance
- Impact assessments for your products and systems
- Briefings for leadership teams
- Implementation planning for regulatory changes
UK & EU Market Access
Navigate the separate UK and EU regulatory systems.
- MHRA and EU pathway assessments
- UK and EU MAA planning
- Product information and packaging requirements
- Post-approval lifecycle in both jurisdictions
Coordinated Across Borders
Map
We identify the requirements of each target market and where they align or differ from your current systems and dossiers.
Harmonise
We build on ICH standards to create a common foundation, adding regional elements only where needed.
Execute
We coordinate submissions, audits and implementation activities across regions and time zones.
Monitor
We track regulatory changes in your markets and help you respond before they affect your business.
Who We Support
- North American companies expanding into the UK and EU
- European and UK companies entering the US or Canadian markets
- Companies with international suppliers, CMOs and CROs
- Sponsors running multi-regional clinical programmes
- Organisations harmonising quality systems across sites and countries
A Genuinely International Team
- Team members based in Canada, the United States and the United Kingdom
- Pharmaceutical careers across North America, the UK and Europe
- Experience with FDA, Health Canada, MHRA and EMA requirements
- Remote support worldwide, with on-site travel when needed
- One coordinated partner instead of separate advisers per market
Common Questions About International Compliance
Can one quality system meet US, Canadian, UK and EU requirements?
In most cases, yes. Building on ICH Q10 and related guidelines gives you a strong common foundation. We then add the specific regional requirements, so you maintain one integrated system rather than several parallel ones.
Do we need separate submissions for the UK and the EU?
Yes. Since the UK left the EU, the MHRA is a separate regulator and products need UK authorisation in addition to EU authorisation. There are routes that can make use of approvals from other regulators, and we help you choose the most efficient approach for your product.
Can you audit suppliers outside North America and Europe?
Yes. We can perform audits remotely or on site, and plan audit programmes for global supply chains based on risk.
How do you keep up with regulatory changes?
Our team follows guidance and legislative updates from the FDA, Health Canada, the MHRA, the EMA and ICH, and we provide clients with practical impact assessments rather than just news alerts.
How are international projects priced?
Defined projects such as a market-entry assessment or an audit are usually fixed-fee. Ongoing coordination and regulatory intelligence can be provided on a retainer. We start with a free discovery call.
Often Combined With
Let's Talk About Your International Plans
Have a compliance challenge or regulatory question? We'd love to hear from you. Fill in the form or reach us directly.