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We cater all the activities related to Pharma companies.
We specialize in regulatory support and can cater to all your needs.
We are a one stop solution for Pharmaceuticals.
Our area of expertise:
1. Registration Assistance
2. Compilation of dossier as per latest country specific guidelines
3. Dossier compilation in Common Technical Dossier (CTD) format for
a. Commonwealth of Independent States (CIS) Guidelines
b. South East / West Europe Guidelines
4. Dossiers compilation in ACTD, CTD, Asian, African, CIS, Central America, South America, North America
5. Dossier conversion (from one country to another)
6. Drug master file (DMF) compilation for open and closed parts
7. Afra Pharma consultant has a specialized division that helps medical device registration, herbal, and dietary product registration
1.Regulatory Support (Regulated and Semi regulated markets)
2.CTD, NeeS, eCTD, DMF (Saudi FDA & GCC as well)
3.Dossier Support (Ready ACTD and CTD dossiers)
4.Clinical and pre-clinical expert reports.Module 3 quality Report
5.BA/BE Studies Clinical Trials
7.Technology transfer (All formulations & API)
8.Exports and tenders
9.Turn-Key Pharma Projects
11.Ready to fill pellets
12.Joint Ventures .
Afra Pharma Consultant
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