. Dealing with eCTD Submissions on Raaj GPRAC’s In-house demo software.
• Awareness of Regulatory System of USFDA, Europe (EMA), RoW, ICH Guidelines.
• Dossier preparation in CTD, ACTD Format, Electronic submissions (NeeS, eCTD).
• Assisted in technical documentation, Workshop/seminar presentation while developing the Regulatory Affairs Consultancy business.
. Dealing with eCTD Submissions on Raaj GPRAC’s In-house demo software.
• Awareness of Regulatory System of USFDA, Europe (EMA), RoW, ICH Guidelines.
• Dossier preparation in CTD, ACTD Format, Electronic submissions (NeeS, eCTD).
• Assisted in technical documentation, Workshop/seminar presentation while developing the Regulatory Affairs Consultancy business.
