Coverage
Every product type, on one record, in every market you file in
Ten-plus jurisdictions are mapped in depth10. A safety event entered once files to each agency that needs it, and one dataset is packaged per market.
Product types
Drugs and devices share one data model, so combination products and device studies inside drug programmes need no second system.
Medicines
Small molecules, biologics, biosimilars and vaccines.
Advanced therapies
Gene therapy, cell therapy and ATMPs, with chain of identity and chain of custody for autologous products.
Devices and diagnostics
Medical devices Class I to III and IVDs Class A to D.
Combination and digital
Combination products, software as a medical device and digital health technologies.
Regulatory regimes and pathways
The drug and device pathways in scope for each regime.
| Jurisdiction | Drug and biologic | Medical device and IVD |
|---|---|---|
| United States (FDA) | IND, NDA, BLA, 505(b)(2), REMS, FAERS | 510(k), PMA, De Novo, IDE, MDR, UDI, SaMD |
| European Union (EMA and notified bodies) | CTR, IMPD, DSUR, RMP | CE mark under MDR and IVDR, PMCF, PSUR, SSCP |
| China (NMPA) | CTA, NDA, CDE review, ChiCTR | Class I, II and III registration, SaMD |
| Japan (PMDA) | J-NDA, SAKIGAKE, bridging studies | PMDA device registration |
| United Kingdom (MHRA) | CTA, NOC, ILAP | UKCA marking |
| Canada (Health Canada) | CTA, NOC | Medical Device Licence, MDSAP |
| Australia (TGA) | CTN, NOC | ARTG inclusion, conformity assessment |
| Brazil (ANVISA) | CTA, registration | INMETRO device certification |
| India (CDSCO) | New Drugs and Clinical Trials Rules 2019 | CDSCO device registration |
| Gulf Cooperation Council | Saudi FDA, UAE MOH and Gulf Central Committee pathways | Saudi FDA, UAE MOH and Gulf Central Committee pathways |
Also in scope: SAHPRA (South Africa), COFEPRIS (Mexico) and WHO Prequalification. Ask us about a market not listed here.
Trial designs
Phase I to IV, decentralised and hybrid, adaptive, platform, basket and umbrella, natural history, observational and real-world evidence studies, post-market clinical follow-up, post-approval studies, compassionate use and expanded access.