#pharmaregulatory

[masuuglobals]

eCTD Software, eCTD Publishing tool, eCTD Submission software

Masuu Global's NextGen eCTD software is an eCTD Software tool, that streamlines creation, validation, publishing, viewing, and reporting of electronic regulatory submissions to ensure compliance with global Health Authorities for life sciences companies.

[masuuglobals]

Medical and Scientific Communication Services Experts

Medical and Scientific Communication services for compliant, high-impact content, MLR-ready materials & global regulatory alignment for MDVs

Medical and Scientific Communication services for compliant, high-impact content, MLR-ready materials & global regulatory alignment for MDVs.

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Market Intelligence Service for Medical Devices Growth

Market Intelligence Service for Medical Devices delivering insights on trends, competitors & regulations to support global market entry.

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Human Factors Engineering for Medical Devices Experts

Human Factors Engineering for Medical Devices ensuring usability, safety, and compliance with FDA, MDR, and global regulatory standards.

Human Factors Engineering for Medical Devices ensuring usability, safety, and compliance with FDA, MDR, and global regulatory standards.

[codresearch]

Expert Regulatory Operations: Precision from Submission to Maintenance

Achieving regulatory success requires more than just a plan; it requires high-level operational execution and meticulous documentation. Specialized expertise in areas like Regulatory Writing, SME Regulatory Services, and Labeling & Artwork Management ensures that every document meets the stringent requirements of health authorities. From initial IND Gap Analysis to ongoing lifecycle maintenance, having a dedicated team of international regulatory experts is essential for maintaining compliance.

COD Research offers an in-house team of regulatory experts who serve as international contact points for your projects. We have supported over 25+ MA Transfer projects and manage 88+ Annual Reports annually, providing the operational depth needed for smooth regulatory oversight. Our services bridge the gap between scientific data and regulatory approval, ensuring your molecule stays on the fast track to success. Master your regulatory operations: Global Regulatory Solutions.

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EU EMA/EDQM SPOR ID Registration and Compliance

Masuu Global offers expert help for ORG_ID and LOC_ID registration in SPOR, ensuring EU EMA/EDQM compliance and efficiency.

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Masuu US Agent: Pre-Assigned Application Numbers & Tracking

Masuu US Agent aids foreign pharma in obtaining pre-assigned application numbers (ANDA, NDA, BLA) via the USFDA’s CDER NextGen portal for smooth tracking.

[masuuglobals]

FDA submission documents, FDA regulatory submissions, FDA Submission

Masuu US Agent provides FDA submission document authorization for foreign pharma, ensuring compliance with USFDA regulations & endorsed forms