Shrikant Gaikar
Regulatory Affairs Assistant Manager @Athena Pharmaceutiques S.A.S.
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Assistant Manager @Athena Pharmaceutiques S.A.S.
Mumbai, IN
Preparation of drug registration dossier for Regulated market for OSD.
EDUCATION
University of Mumbai
Bachelor of Pharmacy (B.Pharm.)
ABOUT SHRIKANT GAIKAR
Preparation of (ANDA-Abbreviated New Drug Application & /or ANDS- Abbreviated New Drug Submissions), Drug Master File (DMF) for Regulated Market as per the CTD/eCTD format and in accordance with Guidelines. Preparation of Drug Master File & Dossier for Regulated and Semi-regulated market. Preparation of Import Drug License Dossier for the China & Taiwan market and responding the technical queries. Provide response to queries & deficiencies for submitted products dossier Evaluation of Analytical Method Validation Report (AMVR) Evaluation of Quality Assurance & Quality control documents Evaluation of Specification, Standard Testing procedure & Certificate of Analysis (COA) of Products & Raw materials Preparation & Evaluation of Stability Study Report Preparation of Certificate of Analysis (COA) Evaluation of Reference/Working standard & Characterization Data Preparation of Annual updates & / amendments of Drug Master File Sending samples & Documents to DCGI/CDTL/IPC Department Supporting to licensing dept. for COPP to FDA Knowledge of CTD & eCTD Format for preparation of DMF & Dossier. Knowledge of ICH Guidelines Knowledge of GMP guidelines Knowledge of Title 21 CFR (Code Federal Regulations) FDA
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.