Regulatory filing and License application
Regulatory Affairs- Executive
Rachem Pharma Ltd
From December 2011
Compilation of ANDAs for EUROPE and US Markets as per CTD Format.
Preparation and compilation of ANDS in CTD format to HEALTH CANADA.
Preparation and compilation of DMFs & Dossiers in CTD format to ROW
Evaluation of the queries received from respective country agencies and to respond on time.
Preparing Specification & COA.
Compilation and submission of Technical Documents for License
Experiences of one year
Qualifications & Certifications
Sai pranavi college of Pharmacy