profilePage

I have done M.pharm in Pharmaceutics.
 
My day to day activity was reated to analyzing post approval changes and filing the apppropriate    document for approval of change in US market.

I have worked on CTD filing for Annual Reportable Changes, CBE - 0, CBE- 30 and Prior Approval Supplement submission

I have gained knowledge related to:

Regulatory Affairs
 -  Knowledge of post approval changes guidelines in US for CMC  Changes.
 -  Change control Management in Trackwise Software.
 - eCTD filing on DCM & Citrix Software.
 - Knowledge of Drug Approval  Process in US.
    etc.
  


�ݺ�ߣ

Vamshikrishna Veldandi