Fenil Shah
Founder & CEO at S V Healthcare
Based in Ahmedabad, India
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Seniority
C-Team
Department
General Business & Management
Location
Ahmedabad
Industry
Pharmaceutical Manufacturing
Company size
17
Contact information
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f•••••••@svhealthcare.in
Phone
5 credits+91 ••• •••• ••••
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Background
About Fenil Shah
Summary of professional experience - Rich experience of filling of dossiers for EU (through DCP, National, MRP and Central procedure), US, Ukraine, Russia Latin America etc- Hands on experience for dossier submission in EU via CESP (Common European Submission Platform) & in US via ESG (Electronic Submission Gateway)- Responsible for handling deficiencies received from various agencies and Clients - Establishment eCTD software - Filling of dossier in NeeS, eCTD format - SPL submission - Reviewing labeling and artworks managing available resources effectively to reduce time and cost to achieved target. Overall experience in planning, coordinating, compiling of MAA submissions (NeeS, eCTD format) and associated amendments. Handling product life-cycle management from submission to approval to post approval amendment.
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