Regulatory And Dossier Support
- Our team of regulatory affair experts are well versed with global Regulatory bodies’ requirement with overall 1000 product submission across 70 countries.
- We can provide dossiers matching following categories:
- Common Technical Document (CTD)
- Asean Common Technical Document (ACTD)
- Electronic Common Technical Document (eCTD)
- Country Specific
- We offer regulatory support towards dossier queries from Authorities to ensure the timely and accurate regulatory response that helps successful product approval in shortest possible time.
- Regulatory review of dossiers to identify the deficiencies and make dossiers filing ready.
- Variation filing with regulatory bodies according to changing guidelines.
