Regulatory affairs professional having two years of experience in pharmaceutical regulatory division. Currently working as Executive –Regulatory affairs at CliniExperts Services (P) Ltd.
During this period I have working on Reviewing technical and scientific data required for submission to CDSCO or DCGI for Global clinical Trial application, New Drug Application, SAE Submission. Review and Submission of technical and other documents/dossiers to CDSCO for- Registration for import of pharmaceutical product, Medical Devices and Cosmetics. Also have experience in, In-vitro diagnostic Kits Import License application requirement, Ethics Committee Registration.
Coordinating with the client’s...