Ramesh Gollapelli Email and Phone Number

Dossier Preparation, review and submission of document/dossier for registration in International markets and ROW countries based on CTD/ACTD format and as per country specific requirements. JOB PROFILE•Preparation, Review and submission of Technical Dossiers as per CTD and ACTD Format. Sterile and orals preparation •Compile the document to be submitted to Row Countries and reviewing of dossiers. •Coordinate with R&D, AR&D, and QA, QC etc. to collect the complete set of documents.•Reviewing manufacturing documents like BMR, process validation Protocol/report, stability protocol/report, sampling protocol, process validation protocol And PDR.•Respond to the queries of Regulatory authorities and customers on time

Young energetic result oriented professional offering 9 years of experience in the field of Regulatory Affairs. Currently associated with Nosch Laboratories Ltd., Hyderabad as “Executive - Regulatory Affairs”. Previously worked with Celon Laboratories Ltd, Hyderabad. Dossier Preparation, review and submission of document/dossier for registration in International markets and ROW countries based on CTD/ACTD format and as per country specific requirements

preparation of dossier ACTD /CTD ROW market