Personal Information
Organization / Workplace
Pune, Maharashtra India
Occupation
Pharmacy Professional
Industry
Medical / Health Care / Pharmaceuticals
Tags
pharma industry
qa
regulatory affairs
usfda
introduction
qc
cro
pharmaceutical
clinical
production
pharma engineering
pharma
quality control
quality system
quality assurance
who
recent approach
warning letter
regulatory agencies
data integrity
biological product
dossier submission procedure
ctd
approval process
drug products
bla
nda
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Presentations
(6)Likes
(5)USFDA NDA Vs BLA
Girish Swami
•
10 years ago
Naavu- process documentation
Chhavijatwani
•
10 years ago
CTD and eCTD
Girish Swami
•
11 years ago
US and EU Submission – Comparative
Girish Swami
•
11 years ago
Pharma regulatory affairs
Girish Swami
•
11 years ago
Personal Information
Organization / Workplace
Pune, Maharashtra India
Occupation
Pharmacy Professional
Industry
Medical / Health Care / Pharmaceuticals
Tags
pharma industry
qa
regulatory affairs
usfda
introduction
qc
cro
pharmaceutical
clinical
production
pharma engineering
pharma
quality control
quality system
quality assurance
who
recent approach
warning letter
regulatory agencies
data integrity
biological product
dossier submission procedure
ctd
approval process
drug products
bla
nda
See more