We provide all kind of consulting services in Regulatory affairs for national and international markets.
- Preparation of Regulatory strategy for dossier submissions
- Dossier compilation for US, Canada, Europe, Australia, New Zealand and Emerging markets (Type: eCTD, CTD, ACTD or country specific)
- Dossier conversion to CTD/ACTD format.
- Regulatory gap assessment and mitigation
- Life cycle management
a) Post approval changes (including site change)
b) Re-registration/Annual updates
c) Change Control Management
d) Labelling updates
e) Regulatory risk assessment
f) Post approval regulatory commitment