North America
- FDA
- Health Canada
NDA, ANDA, 505(b)(2), BLA, 510(k), De Novo, PMA and Canadian NDS/ANDS routes.
Markets
Global Requirements. Local Regulatory Intelligence.
We sequence submissions so that the first approval strengthens the next one, rather than creating a divergent set of country dossiers to maintain.
Europe
- EMA
- EU Member States
- MHRA
- Swissmedic
Centralised, decentralised, mutual recognition and national procedures; EU MDR/IVDR.
Asia-Pacific
- TGA
- Medsafe
- PMDA
- NMPA
- MFDS
- ASEAN
ACTD/CTD hybrids, local testing expectations and in-country representation.
Middle East
- Saudi FDA
- UAE
- Jordan
- Qatar
- Oman
- Kuwait
GCC centralised and national registration routes, GMP and pricing requirements.
Africa
- South Africa
- Egypt
- Kenya
- Nigeria
- Ghana
- Tanzania
- Uganda
SAHPRA, EAC joint assessment, WHO CRP and national dossier formats.
Latin America
- Brazil
- Mexico
- Argentina
- Chile
- Colombia
- Peru
ANVISA, COFEPRIS and regional dossier, legalisation and labeling requirements.
What Each Market Assessment Covers
Plan Your Market Entry on Documented Requirements
We do not publish approval timelines or success rates. Country assessments are built against current published requirements and verified at the point of use.
Regulatory authority overview
Applicable product categories
Available regulatory pathways
Submission and dossier format
Local testing and sample requirements
Legalisation and certification
Labeling requirements
Common deficiencies
Lifecycle obligations