About Me
Priyank Srivastava (M. Pharm)
Regulatory Affairs Specialist
+91-8882524228
priyanksrivastva@gmail.com
Professional Profile: Having work experience of around Six years in various spheres of Pharmaceutical Profession. Before joining Regulatory Affairs, had opportunity to work as QA & QC Head. This prior experience has helped me to visualize the problem and has proved boon to a great extent in getting solutions, which is the prime requirement for any Regulatory Specialist.
Central Drug Standard Control Organization New Delhi (CDSCO).
Medical Devices (extensively with Class II and Class III devices viz. Cardiac Implants, Orthopedic Implants, Grafts, Dental Implants and almost all Notified Devices and for that applying and received more than hundred registrations), Diagnostics Kits (Critical, Semi-critical and Non Critical), Drugs (Humans and Veterinary), API and Cosmetics.
Zonal and Local Drug Authority (FDA)
Manufacturing license, Blood Bank License, Wholesale License and other Permissions.
Wireless Planning & Coordination Wing, Department of Telecommunications (WPC)
Equipment Type Approval (ETA) and Import License for the instuments using wireless viz. Cardiographs and Monitoring Devices
National Institute of Biologicals (NIB)
Performance Evaluation Reports for Critical Diagnostic Kits viz. HIV, HBV, HCV.
Food Safety Standard Authority of India (FSSAI)
New Product Approval and Central License.
Ministry of Environment
Permissions for Import of Re-furbished Machines
Indian Council of Medical Research (ICMR)
Clinical trials Permissions and Permissions for Import and Export of Biologicals.
Pollution Control Board
Permissions for Import of Batteries for Medical Instruments.
Department of Science and Industrial Research (DSIR).
R&D Labs Recognition
I strongly believe that positive & forward looking attitude and updating/adapting ourselves with global regulatory & market requirements helps in this field.
Central Drug Standard Control Organization New Delhi (CDSCO).
Medical Devices (extensively with Class II and Class III devices viz. Cardiac Implants, Orthopedic Implants, Grafts, Dental Implants and almost all Notified Devices and for that applying and received more than hundred registrations), Diagnostics Kits (Critical, Semi-critical and Non Critical), Drugs (Humans and Veterinary), API and Cosmetics.
Zonal and Local Drug Authority (FDA)
Manufacturing license, Blood Bank License, Wholesale License and other Permissions.
Wireless Planning & Coordination Wing, Department of Telecommunications (WPC)
Equipment Type Approval (ETA) and Import License for the instuments using wireless viz. Cardiographs and Monitoring Devices
National Institute of Biologicals (NIB)
Performance Evaluation Reports for Critical Diagnostic Kits viz. HIV, HBV, HCV.
Food Safety Standard Authority of India (FSSAI)
New Product Approval and Central License.
Ministry of Environment
Permissions for Import of Re-furbished Machines
Indian Council of Medical Research (ICMR)
Clinical trials Permissions and Permissions for Import and Export of Biologicals.
Pollution Control Board
Permissions for Import of Batteries for Medical Instruments.
Department of Science and Industrial Research (DSIR).
R&D Labs Recognition
I strongly believe that positive & forward looking attitude and updating/adapting ourselves with global regulatory & market requirements helps in this field.
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