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Sowjanya Solipeta Email
Regulatory Affairs Associate . Masuu Global Solutions
Thornton, CO
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Based in the USA and India, Masuu Global (a sister concern of eCTD Global) which is a vertically integrated Pharma Regulatory consultancy focused on delivering high-quality Regulatory Affairs, Regulatory Operations (eCTD Publishing), Regulatory Labeling, US Agent, cGMP compliance, services, and NextGen eCTD software to Pharmaceuticals, Biopharmaceuticals, Healthcare and Life Sciences industry across the globe with maximum Regulatory specifications & compliance. Regulatory Affairs Services and Software - Dossier writing in CTD, ACTD, eCTD, NeeS and Country specific format - Expertise in handling pre & post-approval submissions for all dosage form - Provide Regulatory insight and strategy for product development - Expertise in dossier gap analysis as per authority standard Regulatory Labeling Services - Expertise in labeling for prescription, OTC, cosmetic and medical device - Authoring of Labeling inserts (PIL, Mockups, Medication Guide, etc) - Assist in tracking of labeling changes (version control management) - Expertise in Artwork creation i.e. Carton and Container and other components Regulatory Operations (eSubmission) Service - Expertise in esubmission management, eCTD, NeeS and pCTD publishing - Assist in Document Level (DLP), Submission Level (SLP) and CSR Level Publishing - Conversion paper format to eCTD format (base-line submission) - Expert advice for a decision on outsourcing or in-house eCTD activities Other Regulatory / US Agent Services - US Agent for FDA communication i.e. meetings, queries, etc - Electronic submission gateway (ESG) and CESP portal setup - Dossier submission via authority gateway (ESG, CESG, CESP) Structured Product Labeling (SPL) Services - Conversion of FDA compliant & validated SPL XML (SPLR4) - Conversion of NDC, ER & GDUFA Identification in SPL XML - Drug Listing of prescription and OTC products (PLR & Non-PLR) in SPL For more info, please contact us at info@masuuglobal.com.Masuu Global Solutions Address
Dexter WayThornton, CO