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.

Pharmaceutical

Life Sciences

Health Care

Medical Devices

Masuu Global Solutions

Masuu Global Solutions' headquarters in Thornton, United States

This department focuses on identifying and developing strategic opportunities to enhance business growth and partnerships.

Business Development

This department manages compliance with regulations and oversees the implementation of regulatory strategies for products.

Regulatory Affairs

The Regulatory Affairs Team at Masuu Global Solutions is responsible for ensuring compliance with regulatory standards across the Pharmaceuticals, Biopharmaceuticals, Healthcare, and Life Sciences industries. The team handles dossier writing in various formats (CTD, ACTD, eCTD, etc.), manages pre and post-approval submissions, provides strategic regulatory insights, and conducts dossier gap analysis. They also oversee regulatory labeling, eSubmission services, act as US Agents for FDA communications, and manage structured product labeling (SPL) services, including SPL XML conversion and drug listing.

Regulatory Affairs Team

This department oversees the strategic direction and leadership of the organization.

Executive Management

This department manages recruitment, employee relations, and workforce development.

Human Resources

This department oversees organizational leadership and operational support.

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People (5)

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Other teams

Regulatory Affairs

Regulatory Affairs Team

Executive Management

Human Resources

Management Services

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People (5)

Jobs (0)

Other teams

Regulatory Affairs

Regulatory Affairs Team

Executive Management

Human Resources

Management Services

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