User Stats

Level: Guru
Member Since: 24/04/2019

Profile Information

First name Jayant
Last name Gangakhedkar
I have professional experience in:

Biotech, Clinical trials, Health tech, Regulatory, other, other

Help us confirm that you're an expert

JAYANT GANGAKHEDKAR ( Expert- Pharmaceuticals)
————————————————————————————————

The expert is having post graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO
He is responsible for evaluating applications pertaining to category of New biological drugs at the second level of evaluation ( immediately after the feeder level) . The responsibility involves critical evaluation the proposals
as per current drug regulations ( Drugs and Cosmetics act 1940 and Rules 1945 along with applicable contemporary guidelines such as ICH/ WHO/ PICS ) and science.

As part of evaluation process the expert is routinely examining the administrative, Chemical manufacturing and control, clinical data in CTD format. Till this date the expert has processed as many as 50 proposals of market authorization (including biosimilars ) and more than 50 proposals of Clinical trials. He can assist the prospective clients on regulatory matters ( regulatory dossiers submissions to health authority for registration, guidance on regulatory pathway, market intelligence, overall market trends)

LinkedIn

http://www.linkedin.com/in/jbg777

Base
Name

Jayant Gangakhedkar

I have professional experience in:

Biotech, Clinical trials, Health tech, Regulatory, other, other

Help us confirm that you're an expert

JAYANT GANGAKHEDKAR ( Expert- Pharmaceuticals)
————————————————————————————————

The expert is having post graduate degree in pharmacy which is duly recognized by the University of Toronto and is currently working as Senior Regulatory Associate at the apex drug regulatory body in India i.e CDSCO
He is responsible for evaluating applications pertaining to category of New biological drugs at the second level of evaluation ( immediately after the feeder level) . The responsibility involves critical evaluation the proposals
as per current drug regulations ( Drugs and Cosmetics act 1940 and Rules 1945 along with applicable contemporary guidelines such as ICH/ WHO/ PICS ) and science.

As part of evaluation process the expert is routinely examining the administrative, Chemical manufacturing and control, clinical data in CTD format. Till this date the expert has processed as many as 50 proposals of market authorization (including biosimilars ) and more than 50 proposals of Clinical trials. He can assist the prospective clients on regulatory matters ( regulatory dossiers submissions to health authority for registration, guidance on regulatory pathway, market intelligence, overall market trends)

LinkedIn

http://www.linkedin.com/in/jbg777