Dhanashree Koli
Regulatory Affairs Trainee @Neon Laboratories Limited
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Trainee @Neon Laboratories Limited
Mumbai, IN
Preparation of dossier as per CTD and ACTD guildlines.2. Preparation of dossier for submissions in Asia and Africa.3. Preparation of SPC and PSUR.4. Checking of Artwork5. Preparation of Tender documents 6. Co-ordinate with respective departments for dossier related documents 7. Handling deficiencies and follow-up8. Resolve queries as per country requirement 9. Application of Test License, Product permissions, COPP, Free sale certificate, Manufacturing and marketing Certificate, Technical staff approval, Renewal of licences, WHO-GMP certificate.10. Handled websites for legal applications-XLNINDIA, WHO-GMP, ONDLS.
EDUCATION
Ramnarain Ruia College - Mumbai
M.sc, Organic Chemistry
Global University of Regulatory Affairs
Post Graduate Diploma in Regulatory Affairs
Annasaheb Vartak College of Arts Kedarnath Malhotra College of Commerce and E S Andrades College of Science Vasai Road Dist Thane 401 202
B.sc (Chemistry)
ABOUT DHANASHREE KOLI
Medicine is not only a science; it is also an art. It does not consist of compounding pills and plasters; it deals with the very processes of life, which must be understood before they may be guided.” - Paracelsus
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.