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Why Masuu?Having expertise in area of pharma regulatory affairs
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QualityIt’s in our DNA
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Life-cycle ManagementWe maintain every detail flawlessly
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Compliance and Confidentiality100% compliance is our priority and
We assure and respect it for every client
Regulatory Affairs
End to end Regulatory Affairs services (dossier submissions (pre approval and post approval), product launch activity, and life-cycle management, compliance and audit support, and regulatory strategy) to pharma and healthcare industry globally
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Regulatory Labeling
End to end Labeling service (Structured product labeling SPLR4 i.e. Establishment Registration, NDC Labeler Code Request, GDUFA Self Identification Request, Drug Listing for PLR and Non-PLR, Artwork Management, Labeling components preparation)
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Regulatory Operations
End to end Regulatory Operations services (publishing and submission, document level publishing, submission level publishing, submission management, submission gateway assistance) to pharma and healthcare industry throughout the globe
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Quality/GMP Audit
Quality & GMP services in compliance with current Industry & Global Health Authorities standards to Pharmaceuticals, Biopharmaceutical, Life-sciences, CDMO industries (Formulation and API).
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