Overview
Each market has its own registration pathway, dossier format, language requirements and timelines. Our regulatory consultants help manufacturers plan and execute registrations efficiently, avoiding costly deficiencies and delays.
We support the full product lifecycle: initial registration, variations, renewals, labelling and artwork compliance, and communication with authorities through local representatives where required.
What we offer
- Registration strategy and regulatory gap analysis per market
- CTD / eCTD dossier compilation and review, including Module 1 country specifics
- Translation and adaptation of SmPC, PIL and labelling
- Submission management and responses to authority queries
- Variations, renewals and post-approval changes
- Coordination with local authorised representatives and marketing authorisation holders
How it works
- 1
Gap analysis
We review your dossier and product against destination requirements.
- 2
Plan
A registration roadmap with timelines, costs and responsibilities.
- 3
Compile & submit
Dossier adaptation, translation and submission through the appropriate channel.
- 4
Approval & maintenance
Query responses, approval follow-up and lifecycle management.
Benefits
Faster approvals
Fewer deficiency letters thanks to market-specific preparation.
Local knowledge
Understanding of authority expectations in the CIS, GCC and African markets.
One coordinator
A single team managing multiple country registrations.
Lifecycle continuity
Variations and renewals handled before they become urgent.
Frequently asked questions
Which markets do you cover?
Our main focus is the CIS and Central Asia, the GCC and selected African and South Asian markets. Contact us with your target list and we will confirm coverage.
Can you act as marketing authorisation holder?
Where the local regulation requires an in-country holder, we coordinate with qualified local partners; we advise on the best structure for your product.
