Area of Interest
Prepare and submission dossier regulated and semi regulated country in CTD,ACTD format,
ANDA Filing, DMF Filing, Registration of products.
o Used databases such as Patent search from patent retriever USPTO, and search skills in e
Orange Book, drugs@FDA, WHO regulatory database, research articles etc.
o Familiar with various Regulatory Guidelines ICH, FDA, EMEA, TGA, CDSCO, etc..
o Knowledge of Code of Federal Regulations.
o Registration of New Drugs in India & US.
o GMP regulationsIndia, WHO, US, Europe.
o Pre & Post Marketing Regulatory Requirements.
o Intellectual Property Rights.
o Clinical Trials & Regulations
o Designing Generic through Non Infringement opinion
o Regulation of Medical Device in US, EUROPE & INDIA
o Proficient in MS Office certificate by NIIT
o Good internet search skill