QSI Associates US based Regulatory and Import/Export experts can assist you in transferring ownership of FDA approved NDAs ANDAs and 505(b)2 applications. ​

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As a strategic partner of QSI Associates, Neocubes Pharma is a global leader in providing end-to-end pharmaceutical solutions, offering a comprehensive range of services to meet the dynamic needs of the industry. Our expertise includes:

• Translation Services: Specialized in medicinal and regulatory document translations in more than 200 languages, Voice over, and localization for global markets.

• Global Regulatory Services: USFDA Regulatory Support (NDA/ANDA, 505b2 application, Pre-IND meeting packages), EU Regulatory support(DCP/MRP or National application, Dossier drafting, eCTD publications, lifecycle management (LCM) like variations/Renewals, Query Phase Management and Different administrative compliance across key markets.

• Global Pharmacovigilance: End to end Pharmacovigilance support for USA/EU/GCC/UK/Canada market, Aggregate report drafting, RMP/REMS drafting, QPPV services for EU/UK, and MICC support

• Artwork Management Services: Full-spectrum artwork and branding solutions, ensuring regulatory compliance and brand integrity.​​