Prashanth Reddy's Colleagues at eCTD Global
Shiv Somani
Director Business Operation & Technical â Regulatory Affairs, Operations & Quality Consultants
Prashanth Reddy's Contact Details
eCTD Global
Prashanth Reddy's Company Details
eCTD Global (a sister concern of Masuu Global LLC, Colorado, USA) is a vertically integrated Pharma Regulatory consultancy focused on delivering high-quality (maximum compliance with regulatory specifications) Regulatory Operations (eCTD, NeeS, pCTD Publishing) Regulatory Labelling, Artwork Creation/Management, and Structured Product Labeling (SPL) services & NextGen eCTD software to Pharmaceuticals, Biopharmaceuticals, Healthcare, and Life Sciences industry across the globe. NextGen eCTD software is a robust, fully compliant, web-based software to create, manage, compile, publish, review, validate, archive the dossier in eCTD format for all eCTD accepting countries i.e. USA, Europe, Canada, GCC, Jordan, Australia, Switzerland, South Africa, and Thailand, etc. with maximum Regulatory (Regional and ICH) specifications, validation, and compliance as per the current and proposed specification/DTD versions.eCTD Global team is expertise in submission management/planning, publishing strategy, document level publishing (DLP), submission level publishing (SLP), submission dispatch, archival and troubleshooting in eCTD/NeeS format for all kind of submissions i.e. DMF, Generic, Brand for the USA, EU/EDQM, Canada, South Africa, Swiss Medic, Australia, GCC, Thailand and Jordan with maximum regulatory specifications, validation, and compliance to ensure error-free, timely and high-quality submissions throughout the dossier lifecycle.Expertise in all kind of Labeling (Generic, Brand, OTC, Rx, PLR, or Non-PLR) and documents authoring, artwork creation and specialization in the conversion of FDA compliant & validated SPL XML (500+ SPL i.e. Drug Listing, Establishment Registration, NDC Labeler Code & GDUFA Identification).eCTD Global has experienced, skilled and dedicated project management teams to monitor, control, and deliver high-quality work according to the client/health authority/project requirements.For more info, please contact us at [email protected].