Masuu with over 280 Subject Matter Experts (SMEs) and a leadership/scientific advisory team featuring former personnel from health authorities like the USFDA, EMA, MHRA, ANVISA, AIFA, TGA, and INVIMA, Masuu Global is recognized as a trusted partner by leading pharmaceutical and life sciences companies worldwide.
With operations across the USA, Canada, India, Ireland, and beyond, Masuu Global has partnered with over 450 international clients, including industry leaders like AbbVie, Allergan, Cipla, Lupin, Mankind, Granules, Otsuka, Reliance, and many others.
Scope of Services and Software:
1. Quality/cGMP and GxP Audits: Six System Audits, Pre-Agency Assessment Audits, Mock Audits, Vendor Qualification Audits, Remediation Audits, Warning Letter Lifting, Import Alert Lifting, and Brown/Green Field projects.
2. CMC Dossier Writing: ANDA, NDA, BLA, DMF, VMF, IND and 505(b)(2) and MAA filing for Global markets
3. Labeling: Preparation Package Insert / SmPC & Artwork and SPL/SPM
4. US Regulatory Agent: Controlled Correspondence and USFDA Communication
5. Other Regulatory Services: DUNS, EFI, ER, Self-Identification, CARES, PDE, and OEL
6. Medical Writing & PV: Clinical & Non-clinical Sections, Case Processing and PADER/PSUR
7. Pharma Software: NextGen eCTD, SPL, eLN, eDQR & PDF Plugin for Cloud and On-Premises
Should you have any questions or wish to explore how we can assist your organization, please feel free to reach out. We look forward to the opportunity of working with you.
For more information do visit our website at www.masuuglobal.com or reach out to us at info@masuuglobal.com and India (+91 63595 96967 / +91 97129 03989 / + 91 78745 88220 and USA +1 754-248-4804).
Company Details
- Employees
- 93
- Founded
- -
- Address
- 2160 Southwest, 20th Street,canada
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- https://www.masuuglobal.com/
- Keywords
- Regulatory Affairs, Regulatory Operations, Regulatory Labeling, eCTD Publishing, eSubmission Management, CSR Level Publishing, Dossier Compilation/Document Authoring, Regional/ICH Attributes/Metadata, Study Tagging File (STF), NeeS/pCTD Publishing, NextGen eCTD Software, eCTD Tracking Checklist, Structured Product Labeling (SPL), Establishment Registration, NDC Labeler Code, Document Level Publishing, Submission Level Publishing, Drug Listing, US Agent Services, ESG/CESG/CESP Setup and Submission, Artwork Creation/Management, GxP Audits, Vendor Audits, 6 Systems Audits, Pre-Agency Assessment Audit, Warning Letter Lifting, Remediation Audit, Agency Inspection Response, Import Alert Clearance, Merger and Acquisition Support, Green Field Project, Brown Field Project, Facility Quality, Equipment Qualification, Computer System Validation, Medical Writing, PV.
- HQ
- Miami, Florida
Masuu Global Solutions Questions
Masuu Global Solutions's website is https://www.masuuglobal.com/
Masuu Global Solutions's LinkedIn profile is https://www.linkedin.com/company/masuu-global
Masuu Global Solutions has
93 employees.
View email and phone details for 93
employees at Masuu Global Solutions.
Masuu Global Solutions's industry is
Pharmaceutical Manufacturing
Masuu Global Solutions's top competitors are
Parexel,
Ectd Now Inc.,
Intas Pharmaceuticals,
Vizen Life Sciences Pvt Ltd,
Sanofi,
Moreing Organic,
Ectd Global (A Subsidiary Of Masuu Group Of Companies),
Freyr Solutions,
Dr. Reddy's Laboratories,
Productlife Group.
Masuu Global Solutions's categories are Pharmaceutical Manufacturing
Masuu Global Solutions's founding year is 2018
