- We have onboard team members with rich experience of Regulatory Affairs for different markets viz.
- Regulated (US, EU, Japan etc), Semi-regulated (Australia, South Africa, Russia, china and other ROW markets), Domestic (India), African countries, and also non-regulated markets.
We can help in following area:
- Support in product development
- Preparation of regulatory strategy
- Dossier writing, compilation (ASEAN, CTD, EU CTD, ANDA, ACTD, NeeS) & review for API & finished product
- Dossier publishing in eCTD -Deficiency response from health agency & client
- Preparation of SmPC, Labelling, Leaflet
- Review of Assessment report from Health Agency against dossier approval
- Variation or supplement filling as per country specific guidance
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