Masuu Global Solutions

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. 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 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).