Personal Information
Entreprise/Lieu de travail
Hyderabad Area, India India
Profession
Regulatory affairs specialist at Graviti Pharma
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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
•...
Documents
(2)J’aime
(5)Innovator Selection (Reference Medicinal Product) by Mr. Pankaj Dhapade
Pankaj Dhapade
•
il y a 10 ans
Patents & market exclusivity
GMP EDUCATION : Not for Profit Organization
•
il y a 11 ans
Risk Assessment for Control of Elemental Impurities.
GMP EDUCATION : Not for Profit Organization
•
il y a 7 ans
Reference standards in Pharmaceutical Industries
bhavanavedantam
•
il y a 10 ans
Reserve sample maintenanace
deepak mishra
•
il y a 9 ans
Personal Information
Entreprise/Lieu de travail
Hyderabad Area, India India
Profession
Regulatory affairs specialist at Graviti Pharma
Secteur d’activité
Medical / Health Care / Pharmaceuticals
À propos
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
•...