From ANVISA in Brazil to the HSA in Singapore, we prepare market-specific dossiers and stand behind our chemistry at every inspection. Explore where we ship and who we've registered with.
Each dot is a market where we hold a live commercial registration. Click one to see the regulatory authority, dossier format, and typical registration timeline for that market.
Each region has its own dossier format, inspection culture, and local partnership model. Our RA team maintains an in-house lead for every one.
Asia-Pacific
Our largest regulatory footprint. India (CDSCO), Singapore (HSA), and Australia (TGA) act as reference markets for smaller APAC dossier submissions.
Dossier framework
CTD · ACTD · eCTD
LATAM
ANVISA in Brazil sets the tone for the region; COFEPRIS, INVIMA, DIGEMID, and ISP follow with market-specific local requirements.
Dossier framework
CTD (Spanish/Portuguese)
Middle East
UAE, Saudi Arabia, and Egypt anchor the region. Increasing GCC harmonisation is easing multi-country submissions, but Egypt still requires distinct EDA filings.
Dossier framework
GCC CTD · EDA CTD
Africa
South Africa (SAHPRA), Nigeria (NAFDAC), and Kenya (PPB) are our current active markets. AMA (African Medicines Agency) harmonisation is expected to reduce per-country burden over the next five years.
Dossier framework
CTD (English)
CIS
Russia and the Central Asian republics operate on a CTD framework with market-specific translation and local-representative requirements.
Dossier framework
CTD (Russian)
Europe
The UK is our current European regulatory anchor. EU expansion through European partners is on the roadmap, backed by our MHRA-aligned quality system.
Dossier framework
eCTD
Every market has a named local partner — a distributor, an in-country representative, or a co-marketing arrangement. Regulatory affairs is always run from India so the QA framework stays unified across markets.
Discuss market entryNamed local partner in every market
In-house RA lead per region
Market-specific dossier prep in-house
20+ live commercial registrations
We add new regulatory dossiers every quarter. If your programme requires registration in a market not on our current map, our RA team scopes the effort as part of the initial engagement.
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