Every product needs a regulatory passport.
Take regulated products global with regulatory services, market-entry support and one clear view of your regulatory readiness.
Start where you are.
Tell us your product, current market and target market. We map the pathway, requirements and documentation needed to launch.
- Pathway assessment
- Registration
- Local representation
Enter. Comply. Prove.
Enter new markets.
Take regulated products from one market into another with pathway assessment, registration, local representation and launch readiness.
- US → Europe
- UK / US → GCC
- Asia → UK / Europe
- Global → ASEAN
Get regulatory work done, anywhere.
Access standalone regulatory services across countries and industries — strategy, classification, documentation, submissions and lifecycle.
- Browse by industry
- Browse by market
- Browse by service
Know where your product stands.
A living regulatory profile for a product, manufacturer or site — approvals, gaps, missing requirements and recommended next steps.
- Readiness by market
- Documentation status
- Regulatory history
Know where your product stands.
A living regulatory profile for a product, manufacturer or manufacturing site. Select a market to see requirements, gaps and next steps.
Four steps to a global product.
Enter new markets. Get the regulatory support you need. Keep everything in one Regulatory Passport.
Tell us about your product
Choose your product category, current market and target market.
Understand what you need
See regulatory requirements, gaps and recommended actions.
Get it done
Purchase regulatory services or engage our team for complete market entry.
Keep your Passport updated
Track approvals, documentation, readiness and ongoing regulatory requirements.
Find regulatory-ready partners globally.
Need a manufacturer, CMO, CDMO, API supplier, testing laboratory or regulatory partner? We identify and assess partners against the regulatory requirements of your target market.
- EU/UK GMP capability
- Relevant manufacturing capability
- Regulated-market experience
- Documentation readiness
- Regulatory due diligence
Built for regulated products.
One platform across global markets.
Initial coverage spans North America, Europe, the UK, the GCC, South Asia and ASEAN.
Global regulation shouldn't require dozens of providers.
Traditional regulatory support is fragmented across countries, consultants, suppliers and spreadsheets. Regulatory Passport brings it into one platform.
Traditional
- 01Find consultant
- 02Explain project
- 03Wait for quote
- 04Manage multiple vendors
- 05Track through emails and spreadsheets
Regulatory Passport
- 01Select product
- 02Select market
- 03Understand requirements
- 04Access services
- 05Track progress and maintain your Passport
Purchase regulatory work like a product.
View price, buy, upload documents and track progress. Complex programmes are scoped and priced individually.
Where do you want to take your product?
Understand the requirements, access regulatory experts and start your next market entry with Regulatory Passport.