Registration
We support registration at every stage - from regulatory documentation to the marketing authorisation - and help complete the transition to the single EAEU rules without any gap in market presence.
Who it's for
- Manufacturers of medicines, supplements and medical devices bringing a product to market in Russia and the EAEU
- Portfolios with unfinished procedures to bring dossiers into line with EAEU requirements
- Companies planning bioequivalence and stability studies
What you get
Preparing and compiling the dossier and regulatory documentation for medicines.
Compliance with EEC Council Decision No. 78 and 'EAEU' status in the register.
Site selection, regulatory procedures, monitoring and reporting.
Registration and organisation of technical and toxicological testing.
Amendments to the dossier and support of subsequent procedures.
How we work
- 01
Portfolio audit
1-2 weeksRisk assessment of marketing-authorisation status across the portfolio.
- 02
Strategy & plan
2 weeksA registration or EAEU-compliance plan and the list of required studies.
- 03
Dossier preparation
by productCompiling and methodologically reviewing the registration documentation.
- 04
Submission & support
per regulatory cycleSupport of the procedure through to the authorisation or 'EAEU' status.
Project example
Objective. Registration of generics with bioequivalence studies and bringing a registered product's dossier into line with EAEU requirements.
What we did. Planned and supported the studies, prepared and reviewed the dossier, and ran the compliance procedure.
Outcome. The products were kept on the market and the dossier moved to EAEU status without a gap.
Let's discuss your case
We'll propose the best format and timeline for your product.