Opening For Medical Services Dept Domestic Regulatory Affairs

Part - I
Having knowledge of Sugam Portal and CDSCO website.
Submission for Mfg. & MKt. Applications ( CT21/CT-18) for IND, New Drug, Subsequent new Drug, FDC. Application of CT-05/CT-04
Application of CT-10/12/13
Application of Import Licenses(CT-16/Form 12/Form 10)
Knowledge Of CDTL submissions.
Import or Export Permit CBN Gwalior
Form 29 application
Preparation of presentation for Subject Expert committee (SEC)
FSSAI applications
Part – II
Preparation of Module 2.4
Non Clinical Overview & Non Clinical Study matrix.
Preparation of Module 2.5
Clinical Overview & Clinical Study matrix.
Preparation of Pack Insert (PI), Patient information leaflet (PIL)& Summary Product Characteristics(SPC).
Approval of artworks.
Literature Search ( Non Clinical , Clinical , Formulation etc).
Preparation of Product Monograph.
Preparation of different types of rationales (for FDC, efficacy, dosing etc.)
Monitoring of Inhouse BABE studies.