Shiv Kumar Somani Email & Phone Number

- eCTD Global (a subsidiary of Masuu Global Solutions) is a vertically integrated Pharma Regulatory consultancy focused on delivering high-quality Regulatory Affairs and Regulatory Operations (eCTD and NeeS) services and NextGen eCTD software- Familiarity with Regulatory Operations (eCTD & NeeS ) and Structured Product Labeling (SPL) with 10+ years of experience - Expertise in eCTD submission management, planning, publishing strategy, and repository- Handled compilation, verification, validation, and life-cycle management of eCTD/NeeS dossiers for the US, EU, GCC, Canada, Australia, Switzerland, and other eCTD and NeeS-accepting countries- Contribute essential and viable knowledge to teams on regulatory operation technical points to assure timely and systematic management of eCTD/NeeS submissions.- Preparation and review of the Drug Listing Data Element (DLDE) section and Content of Labeling (COL) such as prescribing information (PLR), medication guides, cartons, and container labels for branded prescription drugs, generic prescription drugs, and OTC products.- Wide experience and expertise in electronic submission (eCTD & NeeS) and Structured Product Labeling (SPL) as appended below;• 700+ original application submissions to the US, EU, GCC, Canada, Australia, Switzerland, and other eCTD & NeeS accepting countries• 20,000+ life-cycle submissions (amendment to original application and Variations, Renewal, Annual Report and PADER/PSUR) to US, EU, GCC, Canada, Australia, Switzerland, and other eCTD & NeeS accepting countries• 5000+ Structured Product Labeling (Drug Listing, Establishment Registration, NDC Labeler Code and GDUFA Identification)• 500+ BA/BE studies in STF format CSRs, CRFs & Datasets in eCTD /ICH E3 formatPUBLISHING TOOLS:• NextGen eCTD Software• Global Submission Schedule (GSS)• Global Dossier Repository (GDP) • Adobe Acrobat Professional XI• PDF Tool (NextGen PDF Plugin, ISI Toolbox & Evermap)• MD5 Checker and GUID Generator • eCTD Software (NextGen eCTD, PharmaReady, eCTDXPress, KnowledgeNET and Extedo) • eCTD Viewer (eCTDOffice, Rosetta & KnowledgeNET)• eCTD eValidator (Lorenz and Extedo)• ESG, CESG, SR, CESP & Physical Media• DMS (DocuTrack NextGen eDQR) • XML Editor (NotePad++ & Altova XMLSpy)• NextGen SPL Software, Pragmatic Validator & SPL XForm

Listed skills include Regulatory Affairs, Regulatory Submissions, Dra, Splr4, and 45 others.