Personal Information
Organização/Local de trabalho
Hyderabad Area, India India
Cargo
Regulatory affairs specialist at Graviti Pharma
Setor
Medical / Health Care / Pharmaceuticals
Sobre
Regulatory affairs manager in Graviti Pharma from Oct 2016 to till date.
Highly motivated, results-driven Regulatory affairs (Formulation) professional with extensive experience in US-FDA submissions (ANDA, Amendments, labeling, post approval Supplements) and Brazil Anvisa submissions, I have gained knowledge upon regulatory requirements in US, Brazil and China countries. Well versed with complete product lifecycle management (right from inception-review-approval-post approval changes).
Specialties:
Regulatory Document (ANDA, Controlled correspondence, Petitions) compilation, reviewing and submissions [Electronic Submissions (eCTD) using eCTD software (eDUCE)]
Hands-on exposure to
•...
Documentos
(2)Gostaram
(5)Innovator Selection (Reference Medicinal Product) by Mr. Pankaj Dhapade
Pankaj Dhapade
•
Há 10 anos
Patents & market exclusivity
GMP EDUCATION : Not for Profit Organization
•
Há 11 anos
Risk Assessment for Control of Elemental Impurities.
GMP EDUCATION : Not for Profit Organization
•
Há 7 anos
Reference standards in Pharmaceutical Industries
bhavanavedantam
•
Há 10 anos
Reserve sample maintenanace
deepak mishra
•
Há 9 anos
Personal Information
Organização/Local de trabalho
Hyderabad Area, India India
Cargo
Regulatory affairs specialist at Graviti Pharma
Setor
Medical / Health Care / Pharmaceuticals
Sobre
Regulatory affairs manager in Graviti Pharma from Oct 2016 to till date.
Highly motivated, results-driven Regulatory affairs (Formulation) professional with extensive experience in US-FDA submissions (ANDA, Amendments, labeling, post approval Supplements) and Brazil Anvisa submissions, I have gained knowledge upon regulatory requirements in US, Brazil and China countries. Well versed with complete product lifecycle management (right from inception-review-approval-post approval changes).
Specialties:
Regulatory Document (ANDA, Controlled correspondence, Petitions) compilation, reviewing and submissions [Electronic Submissions (eCTD) using eCTD software (eDUCE)]
Hands-on exposure to
•...