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| Home > What We Do |
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| Regulatory Consulting & Approvals |
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Karmic’s core clinical services are delivered on a strong platform of regulatory expertise. We provide
end-to-end regulatory support including Pre-Approval Dossier & Documentation Support, Marketing Authorization
Approval, Post Approval Support and Medical & Technical Writing services to our clients.
Our team comprises of experienced regulatory consultants with 100+ person years experience and strong knowledge
of US-FDA, EU-MHRA and unregulated markets. We further have a strategic partnership with a leading e-submissions
company for CTD/eCTD submission through dedicated gateway. We further have in-house XML programming skills and
documentation expertise to manage the entire filing process smoothly. Our regulatory services include:
- Regulatory Strategy for NCEs, NBEs, Generics, Medical Devices etc.
- Local Regulatory Approvals (DCGI, IRB/IEC)
- Core Dossier Management
- NDA/ANDA Filings, DMF’s etc.
- ICH/ASEAN based CTD/eCTD Regulatory Submissions
- CTD Summaries, Overview and Expert Report
- Regulatory Intelligence & Updates
- Intellectual Property Searches
- Regulatory Training
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| Featured Case Study |
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| Karmic currently supports a Top 5 Global Pharmaceutical giant for data management across 15+ studies in multiple therapeutic areas over 14+ geographies across the globe |
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